AzTrials
AzTrials

Coronary Artery DiseaseNCT02173379

Absorb IV Randomized Controlled Trial

A study testing Absorb BVS and XIENCE in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Abbott Medical Devices at 120 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Absorb BVS and XIENCE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,604 participants
Where
120 sitesin 5 countries
Study dates
Jul 2014to 6 Apr 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
  3. Subject must have evidence of myocardial ischemia (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:
  4. Unstable angina or NSTEMI within 2 weeks of the index procedure.
  5. STEMI > 72 hours ≤ 2 weeks prior to the index procedure. Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.
  6. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR). (Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)
  7. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  8. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
  9. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.
  10. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.

Angiographic Inclusion Criteria:

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.

  1. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥50% and < 100%, with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1, and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).
  2. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
  3. Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.
  2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  3. Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.
  5. Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:
  6. Subject requires coumadin or any other agent for chronic oral anticoagulation.
  7. Subject is likely to become hemodynamically unstable due to their arrhythmia.
  8. Subject has poor survival prognosis due to their arrhythmia.
  9. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.
  10. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
  11. Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions < 30 days after the index procedure.
  12. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  13. At the time of screening, the subject has a malignancy that is not in remission.
  14. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  15. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  16. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).
  17. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  18. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  19. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
  20. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.
  21. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).
  22. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
  23. Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.
  24. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
  25. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  26. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

  1. Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):
  2. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
  3. TIMI flow grade <3 (per visual estimation).
  4. Any angiographic complication (e.g. distal embolization, side branch closure).
  5. Any dissection NHLBI grade D-F.
  6. Any chest pain lasting > 5 minutes.
  7. Any ST-segment depression or elevation lasting > 5 minutes.
  8. Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
  9. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
  10. Lesion located within 3 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX).
  11. Lesion involving a bifurcation with a:
  12. side branch ≥ 2 mm in diameter, or
  13. side branch with either an ostial or non-ostial lesion with diameter stenosis >50%, or
  14. side branch requiring dilatation
  15. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:
  16. Extreme angulation (≥ 90°) proximal to or within the target lesion.
  17. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
  18. Moderate or heavy calcification proximal to or within the target lesion. If intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  19. Lesion or vessel involves a myocardial bridge.
  20. Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.
  21. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Trial locations and contacts

120 sites in 5 countries.

120 sites in 5 countries

United States98 sites

  • Northwest Texas Healthcare System

    Amarillo, Texas, 79106

  • Anmed Health Medical Center

    Anderson, South Carolina, 29621

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48197

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Seton Medical Center

    Austin, Texas, 78705

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Our Lady of Lourdes Medical Center

    Camden, New Jersey, 08103

  • Holy Spirit Hospital

    Camp Hill, Pennsylvania, 17011

  • Aultman Hospital

    Canton, Ohio, 44710

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • Carolinas Medical Center-Northeast

    Charlotte, North Carolina, 28203

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Novant Health Heart & Vascular Institute/Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Carolinas Medical Center-Pineville

    Charlotte, North Carolina, 28210

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP

    Columbia, Missouri, 65201

  • Providence Hospital

    Columbia, South Carolina, 29204

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • John Muir Health Concord

    Concord, California, 94520

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Harper University Hospital

    Detroit, Michigan, 48201

  • St John Hospital & Medical Center

    Detroit, Michigan, 48236

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Elkhart General Hospital

    Elkhart, Indiana, 46514

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Providence Reg Med Ctr Everett

    Everett, Washington, 98201

  • NewYork-Presbyterian/Queens

    Flushing, New York, 11355

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Washington Hospital

    Fremont, California, 94538

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Pinnacle Health Hospitals

    Harrisburg, Pennsylvania, 17105-8700

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Franciscan St Francis Health

    Indianapolis, Indiana, 46237

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Scripps Memorial Hospital La Jolla

    La Jolla, California, 92037

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University Of Kentucky Hospital

    Lexington, Kentucky, 40506

  • Nebraska Heart Institute Heart Hosp.

    Lincoln, Nebraska, 68526

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • St. Patrick Hospital

    Missoula, Montana, 59802

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYP Weill Cornell Medical Center

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Medstar Health Research Institute/ Medstar Washington Hospital Center

    Northwest, Washington, 20010

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Integris Baptist Medical Center, Inc.

    Oklahoma City, Oklahoma, 73112

  • CHI Health Bergan Mercy

    Omaha, Nebraska, 68124

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Upmc Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Rex Hospital, Inc.

    Raleigh, North Carolina, 27607

  • WakeMed

    Raleigh, North Carolina, 27610

  • St. Joseph Medical Center

    Reading, Pennsylvania, 19605

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • Rochester General Hospital

    Rochester, New York, 14621

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Univ Of California Davis Med Ctr

    Sacramento, California, 95817

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85258

  • St. John's Hospital

    Springfield, Illinois, 62769

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Hospital and Clinics

    Stanford, California, 94305

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • St. Joseph's Hospital Health Center

    Syracuse, New York, 13203

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

  • Little Company Of Mary Hospital

    Torrance, California, 90503

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • East Texas Medical Center

    Tyler, Texas, 75701

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27103

  • Genesis Hospital

    Zanesville, Ohio, 43701

Other trials in United States

Germany11 sites

  • Segeberger Kliniken GmbH - Herzzentrum

    Bad Segeberg, Schleswig-Holstein, 23795

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    Bernau, State of Berlin, 16321

  • Universitatsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53105

  • Elisabeth-Krankenhaus

    Essen, North Rhine-Westphalia, 45138

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • University Giessen

    Giessen, Hesse, 35392

  • Kliniken Oberallgau gGmbH

    Immenstadt im Allgäu, Bavaria, 87509

  • Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH

    Kempten (Allgäu), Bavaria, 87439

  • Johannes Gutenberg-Universitaet

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum Oldenburg

    Oldenburg, Lower Saxony, 26133

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Australia6 sites

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Perth Hospital

    Perth, Western Australia, 6001

Other trials in Australia

Canada4 sites

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • CHUM-Hotel Dieu

    Montreal, Quebec

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Singapore1 site

  • National Heart Centre, Singapore, Pte, Ltd.

    Singapore, 169609

Other trials in Singapore

About this study

Official title: A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.

Read the detailed description

ABSORB IV:

  1. Primary Objective:
  • To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
  • To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
  1. Secondary Objectives:
  • To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
  • To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.

The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4 and 5 years.

Note: All registered subjects in ABSORB IV will be followed up to 5 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.

Being tested
Absorb BVS, XIENCE
Keywords
Absorb™ BVS, Angioplasty, Bioabsorbable, BVS, Coronary Artery Disease, Coronary Artery Endothelial Responsiveness, Coronary artery restenosis, Coronary artery stenosis, Coronary scaffold, Coronary Stent, Drug eluting stents, Everolimus, Myocardial ischemia, Stent thrombosis, Stents
Medical subject headings
Coronary Artery Disease, Coronary Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Absorb BVSDevice

    • Scaffold diameters: 2.5, 3.0 and 3.5 mm
    • Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
    • Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.
    • The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.

    Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

  • XIENCEDevice

    Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).

    • Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition
    • Stent lengths: 8, 12, 15, 18, 23, and 28 mm
    • For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices

    To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Study groups in NCT02173379
Study groupRoleWhat they receive
Absorb BVSExperimentalSubjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Receives: Device: Absorb BVS
XIENCEActive comparatorSubjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only)
Receives: Device: XIENCE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Target Lesion Failure (TLF)

    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))

    Measured: 30 days

Secondary outcomes (168)

  1. TLF at 1-year, Non-inferiority Against the Control

    One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.

    Measured: 1 year

  2. Angina at 1-year, Non-inferiority Against the Control

    • Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
    • This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.

    Measured: 1 year

  3. Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)

    Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.

    Measured: In-hospital (≤ 7days)

  4. Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)

    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).

    Measured: In-hospital (≤ 7days)

  5. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: In-hospital (≤ 7 days post index procedure)

  6. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 30 days

  7. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 90 days

  8. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 180 days

  9. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 270 days

  10. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 1 year

  11. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 2 years

  12. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 3 years

  13. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 4 years

  14. Number of Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    For the All-Cause Mortality data, the denominator excludes participants who are lost-to-follow-up or withdrawn (by subject or physician) through a given timepoint without any DMR event (all death, MI and revascularization, respectively). If these participants were included in the denominator in each arm, that would equate to assuming that these participants are alive, potentially underestimating the death rate by inflating the denominator.

    Measured: 5 years

  15. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: In-hospital (≤ 7 days post index procedure)

  16. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 30 days

  17. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 90 days

  18. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 180 days

  19. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 270 days

  20. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 1 year

  21. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 2 years

  22. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 3 years

  23. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 4 years

  24. Number of Participants With Myocardial Infarction (MI)

    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

    Measured: 5 years

  25. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: In-hospital (≤ 7 days post index procedure)

  26. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 30 days

  27. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 90 days

  28. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 180 days

  29. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 270 days

  30. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 1 year

  31. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 2 year

  32. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 3 years

  33. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 4 years

  34. Number of Participants With Target Vessel Myocardial Infarction (TV-MI)

    Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)

    Measured: 5 years

  35. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: In-hospital (≤ 7 days post index procedure)

  36. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 30 days

  37. Number of Participants withTarget Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 90 days

  38. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 180 days

  39. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 270 days

  40. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 1 year

  41. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 2 years

  42. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 3 years

  43. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 4 years

  44. Number of Participants With Target Lesion Revascularization (TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.

    Measured: 5 years

  45. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: In-hospital (≤ 7 days post index procedure)

  46. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 30 days

  47. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 90 days

  48. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 180 days

  49. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 270 days

  50. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 1 year

  51. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 2 years

  52. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 3 years

  53. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 4 years

  54. Number of Participants With Ischemia Driven TLR (ID-TLR)

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography

    Measured: 5 years

  55. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: In-hospital (≤ 7 days post index procedure)

  56. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 30 days

  57. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 90 days

  58. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR.

    -TVR includes all TVR, excluding TLR

    Measured: 180 days

  59. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 270 days

  60. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 1 year

  61. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 2 years

  62. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 3 years

  63. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 4 years

  64. Number of Participants With Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 5 years

  65. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: In-hospital (≤ 7 days post index procedure)

  66. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 30 days

  67. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 90 days

  68. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 180 days

  69. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 270 days

  70. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 1 year

  71. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 2 years

  72. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 3 years

  73. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 4 years

  74. Number of Participants With ID-TVR Excluding TLR

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

    Measured: 5 years

  75. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: In-hospital (≤ 7 days post index procedure)

  76. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 30 days

  77. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 90 days

  78. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 180 days

  79. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 270 days

  80. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 1 year

  81. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 2 years

  82. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 3 years

  83. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 4 years

  84. Number of Participants With All Coronary Revascularization

    Revascularization includes TLR, TVR excluding TLR, and non TVR.

    Measured: 5 years

  85. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: In-hospital (≤ 7 days post index procedure)

  86. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 30 days

  87. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 90 days

  88. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 180 days

  89. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 270 days

  90. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 1 year

  91. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 2 years

  92. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 3 years

  93. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 4 years

  94. Number of Participants Experienced All Death/All MI

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
    • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
    • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

    -Non-Q wave MI: Those MIs which are not Q-wave MI

    Measured: 5 years

  95. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: In-hospital (≤ 7 days post index procedure)

  96. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 30 days

  97. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 90 days

  98. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 180 days

  99. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 270 days

  100. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 1 year

  101. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 2 years

  102. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 3 years

  103. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 4 years

  104. Number of Participants Experienced Cardiac Death/All MI

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Measured: 5 years

  105. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: In-hospital (≤ 7 days post index procedure)

  106. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 30 days

  107. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 90 days

  108. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 180 days

  109. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 270 days

  110. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 1 year

  111. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 2 years

  112. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 3 years

  113. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 4 years

  114. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 5 years

  115. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: In-hospital (≤ 7 days post index procedure)

  116. Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 30 days

  117. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 90 days

  118. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 180 days

  119. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 270 days

  120. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 1 year

  121. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 2 years

  122. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 3 years

  123. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 4 years

  124. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

    Measured: 5 years

  125. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: In-hospital (≤ 7 days post index procedure)

  126. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 30 days

  127. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 90 days

  128. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 180 days

  129. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 270 days

  130. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 1 year

  131. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 2 years

  132. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 3 years

  133. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 4 years

  134. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

    Measured: 5 years

  135. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: In-hospital (≤ 7 days post index procedure)

  136. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 30 days

  137. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 90 days

  138. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 180 days

  139. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 270 days

  140. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 1 year

  141. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 2 years

  142. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 3 years

  143. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 4 years

  144. Number of Participants Experienced Death/All MI/All Revascularization (DMR)

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

    Measured: 5 years

  145. Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 0 - 24 hours post stent implantation

  146. Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: >24 hours - 30 days post stent implantation

  147. Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

    Measured: 30 days - 1 year post stent implantation

  148. Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)

    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained

    Measured: 0 to 730 Days

  149. Number of Participants With Rehospitalization

    • Coronary artery disease (CAD) related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 30 days

  150. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 90 days

  151. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 180 days

  152. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 270 days

  153. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 1 year

  154. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 2 years

  155. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 3 years

  156. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 4 years

  157. Number of Participants With Rehospitalization

    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

    Measured: 5 years

  158. Number of Participants With Repeat Coronary Arteriography

    Measured: In-hospital (≤ 7 days post index procedure)

  159. Number of Participants With Repeat Coronary Arteriography

    Measured: 30 days

  160. Number of Participants With Repeat Coronary Arteriography

    Measured: 90 days

  161. Number of Participants With Repeat Coronary Arteriography

    Measured: 180 days

  162. Number of Participants With Repeat Coronary Arteriography

    Measured: 270 days

  163. Number of Participants With Repeat Coronary Arteriography

    Measured: 1 year

  164. Number of Participants With Repeat Coronary Arteriography

    Measured: 2 years

  165. Number of Participants With Repeat Coronary Arteriography

    Measured: 3 years

  166. Number of Participants With Repeat Coronary Arteriography

    Measured: 4 years

  167. Number of Participants With Repeat Coronary Arteriography

    Measured: 5 years

  168. Number of Participants With Target Lesion Failure (TLF)

    The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion6 Apr 2022
  4. Study completion6 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,604 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02173379
Sponsor's protocol ID
10-392 C
Status last verified
Oct 2023
First submitted
9 Jun 2014
Last updated
30 Oct 2023
Data monitoring committee
Yes

Publications

  • Power DA, Camaj A, Kereiakes DJ, Ellis SG, Gao R, Kimura T, Ali ZA, Stockelman KA, Dressler O, Onuma Y, Serruys PW, Stone GW; ABSORB Investigators. Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program. JACC Cardiovasc Interv. 2025 Jan 13;18(1):1-11. doi: 10.1016/j.jcin.2024.08.050.

    PubMed 39814482

  • Stone GW, Kereiakes DJ, Gori T, Metzger DC, Stein B, Erickson M, Torzewski J, Kabour A, Piegari G, Cavendish J, Bertolet B, Stockelman KA, West NEJ, Ben-Yehuda O, Choi JW, Marx SO, Spertus JA, Ellis SG; ABSORB IV Investigators. 5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique. J Am Coll Cardiol. 2023 Jul 18;82(3):183-195. doi: 10.1016/j.jacc.2023.05.003. Epub 2023 May 17.

    PubMed 37207924

  • Stone GW, Ellis SG, Gori T, Metzger DC, Stein B, Erickson M, Torzewski J, Williams J Jr, Lawson W, Broderick TM, Kabour A, Piegari G, Cavendish J, Bertolet B, Choi JW, Marx SO, Genereux P, Kereiakes DJ; ABSORB IV Investigators. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. Lancet. 2018 Oct 27;392(10157):1530-1540. doi: 10.1016/S0140-6736(18)32283-9. Epub 2018 Sep 25.

    PubMed 30266412

Questions about this trial

What is this clinical trial studying?

A study testing Absorb BVS and XIENCE in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Abbott Medical Devices at 120 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Germany, Australia, Canada, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Target Lesion Failure (TLF) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02173379, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.

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