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AzTrials

Coronary Artery DiseaseABSORB-IIINCT01751906

ABSORB III Randomized Controlled Trial (RCT)

A study testing Absorb BVS and XIENCE in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Abbott Medical Devices at 192 sites in 2 countries.

Completed

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

Official record
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Trial summary

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS). The ABSORB III includes additional two trials i.e. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Absorb BVS and XIENCE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,008 participants
Where
192 sitesin 2 countries
Study dates
Dec 2012to Oct 2020
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., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
  4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. 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.
  6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
  7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

  1. One or two de novo target lesions:
  2. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
  3. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
  4. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
  5. 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 TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.
  6. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
  7. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
  8. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist 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 aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  4. Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
  5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  6. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:
  7. Subject requires coumadin or any other agent for chronic oral anticoagulation.
  8. Subject is likely to become hemodynamically unstable due to their arrhythmia.
  9. Subject has poor survival prognosis due to their arrhythmia.
  10. 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 ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
  11. 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 24 hours and 30 days before the index procedure if successful and uncomplicated.
  12. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure
  13. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  14. At the time of screening, the subject has a malignancy that is not in remission.
  15. 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.
  16. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  17. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
  18. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  19. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  20. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening.
  21. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  22. 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.).
  23. 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.
  24. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
  25. 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.
  26. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  27. 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 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. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
  2. Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended.
  3. TIMI Grade-3 flow (per visual estimation).
  4. No angiographic complications (e.g. distal embolization, side branch closure).
  5. No dissections NHLBI grade D-F.
  6. No chest pain lasting > 5 minutes.
  7. No ST depression or elevation lasting > 5 minutes.
  8. Lesion is located in left main.
  9. Aorto-ostial RCA lesion (within 3 mm of the ostium).
  10. Lesion located within 3 mm of the origin of the LAD or 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 IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  19. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
  20. Lesion or vessel involves a myocardial bridge.
  21. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
  22. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
  23. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Trial locations and contacts

192 sites in 2 countries.

192 sites in 2 countries

United States190 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106

  • Northwest Texas Healthcare System

    Amarillo, Texas, 79106

  • AnMed Health

    Anderson, South Carolina, 29621

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • University Hospital

    Augusta, Georgia, 30901

  • Seton Medical Center Austin

    Austin, Texas, 78705

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Joseph Hospital

    Bellingham, Washington, 98225

  • Baptist Medical Center Princeton

    Birmingham, Alabama, 35211

  • University of Alabama Hospital

    Birmingham, Alabama, 35233

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Brandon Regional Hospital

    Brandon, Florida, 33511

  • St. Elizabeth's Medical Center of Boston

    Brighton, Massachusetts, 02135

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Holy Spirit Hospital

    Camp Hill, Pennsylvania, 17011

  • Aultman Hospital

    Canton, Ohio, 44710

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University Hospital

    Cincinnati, Ohio, 45206

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Tri-Health Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UCH-Memorial Health Systems

    Colorado Springs, Colorado, 80909

  • Boone Hospital Center

    Columbia, Missouri, 65201

  • Sisters of Charity Providence Hospital

    Columbia, South Carolina, 29204

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • John Muir Medical Center - Concord Campus

    Concord, California, 94520

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital

    Dallas, Texas, 75204

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Harper University Hospital

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John Hospital & Medical Center

    Detroit, Michigan, 48236

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Duke University Medical Center

    Durham, North Carolina, 27110

  • Elkhart General Healthcare

    Elkhart, Indiana, 46514

  • EMH Healthcare

    Elyria, Ohio, 44035

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • UPMC Hamot

    Erie, Pennsylvania, 16550

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Thomas Hospital

    Fairhope, Alabama, 36532

  • Cleveland Cln Fairview Hospital

    Fairview Park, Ohio, 44126

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Medical Center of the Rockies

    Fort Collins, Colorado, 80538

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Mary Washington Hospital

    Fredericksburg, Virginia, 22401

  • Washington Hospital

    Fremont, California, 94538

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Chandler Regional Medical Center

    Gilbert, Arizona, 85297

  • Greenville Memorial Hospital of the Greenville Health System

    Greenville, South Carolina, 29605

  • St. Francis Health System

    Greenville, South Carolina, 29607

  • Cooper University Hospital

    Haddon Heights, New Jersey, 08035

  • Our Lady of Lourdes Medical Center

    Haddon Heights, New Jersey, 08035

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • MedStar Washington Hospital Center

    Hyattsville, Maryland, 20782

  • Union Memorial Hospital

    Hyattsville, Maryland, 20782

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • Baptist Medical Center - Downtown

    Jacksonville, Florida, 32207

  • University of Florida UF Health

    Jacksonville, Florida, 32209

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • The University of Kansas Hospital and Medical Center

    Kansas City, Kansas, 66106

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • St. Mary Medical Center

    Langhorne, Pennsylvania, 19047

  • Sparrow Hospital

    Lansing, Michigan, 48910

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Nebraska Heart Hospital

    Lincoln, Nebraska, 68526

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • St. Joseph's Hospital Health Center

    Liverpool, New York, 13088

  • Good Samaritan Hospital

    Los Angeles, California, 90017

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90043

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Long Island Jewish Medical Center

    Manhasset, New York, 11030

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Banner Heart Hospital

    Mesa, Arizona, 85206

  • University of Miami Hospital

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • St. Patrick Hospital

    Missoula, Montana, 59802

  • Sutter Central Valley Hospitals dba Memorial Medical Center

    Modesto, California, 95355

  • Baptist Medical Center South

    Montgomery, Alabama, 36117

  • Morristown Medical Center

    Morristown, New Jersey, 07962

  • InterMountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06520

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • New York Presbyterian Hospital-Cornell University

    New York, New York, 10065

  • Lennox Hill Hospital,

    New York, New York, 10075

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • MediQuest Research Group Inc at Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Palm Beach Gardens Medical Center

    Palm Beach Gardens, Florida, 33410

  • Bay County Health Systems

    Panama City, Florida, 32401

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Baptist Hospital

    Pensacola, Florida, 32501

  • Saint Francis Medical Center

    Peoria, Illinois, 61614

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • UPMC Shadyside Hospital

    Pittsburgh, Pennsylvania, 15219

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Rex Hospital

    Raleigh, North Carolina, 27607

  • WakeMed

    Raleigh, North Carolina, 27610

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • North Memorial Medical Center

    Robbinsdale, Minnesota, 55422

  • Rochester General Hospital

    Rochester, New York, 14621

  • Strong Memorial Hospital

    Rochester, New York, 14627

  • William Beaumont Hospital

    Royal Oak, Michigan, 48703

  • Mercy General Hospital

    Sacramento, California, 95816

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Sutter Medical Center

    Sacramento, California, 95819

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21804

  • Methodist Texsan Hospital

    San Antonio, Texas, 78201

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85260

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57104

  • St. John's Hospital

    Springfield, Illinois, 62701

  • Mercy Hospital Springfield

    Springfield, Missouri, 65807

  • PeaceHealth Sacred Heart Medical Center

    Springfield, Oregon, 97477

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • St. Anthony's Medical Center

    St Louis, Missouri, 63129

  • St. Vincent's Medical Center

    Stamford, Connecticut, 06905

  • Stanford Hospital and Clinics

    Stanford, California, 94305

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Tampa General Hospital

    Tampa, Florida, 33609

  • Florida Hospital Pepin Heart Institute

    Tampa, Florida, 33613

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • Mercy St. Vincent's Medical Center

    Toledo, Ohio, 43608

  • Little Company Of Mary Hospital

    Torrance, California, 90503

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Hillcrest Medical Center

    Tulsa, Oklahoma, 74104

  • North Mississippi Medical Center Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

  • East Texas Medical Center

    Tyler, Texas, 75701

  • Trinity Mother Frances Hospital Regional Healthcare Center

    Tyler, Texas, 75701

  • Mercy Medical

    West Des Moines, Iowa, 50266

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Pinnacle Health at Harrisburg Hospital

    Wormleysburg, Pennsylvania, 17043

  • St. Joseph Medical Center

    Wyomissing, Pennsylvania, 19610

  • York Hospital

    York, Pennsylvania, 17405

  • St. Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

  • Genesis-Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

Australia2 sites

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

Other trials in Australia

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.

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and 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.

Read the detailed description

ABSORB III RCT:

  1. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
  2. Powered Secondary Objectives:
  3. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice. The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III. The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.
  4. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

Being tested
Absorb BVS, XIENCE
Keywords
Absorb™ BVS, Angioplasty, Bioabsorbable, BVS, Bioresorbable, 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 The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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.
    • 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
    • Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
    • 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 NCT01751906
Study groupRoleWhat they receive
Absorb BVSExperimentalSubjects receiving Absorb BVS
Receives: Device: Absorb BVS
XIENCEActive comparatorSubjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
Receives: Device: XIENCE

What is being measured

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

  1. Number of Cardiac Death/TV-MI/ID-TLR (TLF)

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Measured: 1 year

Secondary outcomes (35)

  1. Number of Participants With Powered Secondary Endpoint: Angina

    Angina is defined as the first adverse event resulting in the site diagnosis of angina.

    Measured: 1 year

  2. Number of Participants With Powered Secondary Endpoint: All Revascularization

    This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.

    Measured: 1 year

  3. Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)

    This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.

    Measured: 1 year

  4. 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: On day 0 (the day of procedure)

  5. 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: On day 0 (the day of procedure)

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

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    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.

    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.

    Measured: 0 to 5 years

  7. Number of Participants With All Myocardial Infarction (MI)

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

    Measured: 0 to 5 years

  8. Number of Participants With All 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 (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

    Measured: 0 to 5 years

  9. Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (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.

    Measured: 0 to 5 years

  10. Number of Participants With All Revascularization

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

    Measured: 0 to 5 years

  11. Number of 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: 0 to 5 years

  12. Number of Cardiac 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: 0 to 5 years

  13. Number of 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: 0 to 5 years

  14. Number of 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: 0 to 5 years

  15. Number of Participants With 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: 0 to 5 years

  16. Number of Death/All MI/All Revascularization (DMR)

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

    Measured: 0 to 5 years

  17. Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

    Measured: ≤ 1 Day

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

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

    Measured: 0 to 30 Days

  19. Number of Participants With Subacute Stent/Scaffold Thrombosis

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

    Measured: >1 to 30 Days

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

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

    Measured: 31 to 365 Days

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

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

    Measured: 366 to 393 Days

  22. Number of Participants With Cumulative Stent/Scaffold Thrombosis

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

    Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

    Measured: 0 to 1853 Days

  23. Pre-Procedure Minimum Lumen Diameter (MLD)

    Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

    Measured: < or = 1 day

  24. Pre-Procedure Percent Diameter Stenosis (%DS)

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Measured: < or = 1 day

  25. Post-Procedure In-Segment Minimum Lumen Diameter (MLD)

    Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

    In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

    Measured: ≤ 7 days post index procedure

  26. Post-Procedure In-Segment Percent Diameter Stenosis (%DS)

    Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

    Measured: ≤ 7 days post index procedure

  27. Post-Procedure In-Device Minimum Lumen Diameter (MLD)

    Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

    In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold

    Measured: ≤ 7 days post index procedure

  28. Post-Procedure In-Device Percent Diameter Stenosis (%DS)

    Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    Measured: ≤ 7 days post index procedure

  29. Post-Procedure In-Device Acute Gain

    The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

    Measured: ≤ 7 days post index procedure

  30. Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)

    • Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.
    • Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.

    Measured: From Post procedure to 3 Years

  31. Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

    Measured: 3 Years

  32. Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

    Measured: 3 Years

  33. Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

    Measured: 3 Years

  34. Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

    Measured: 3 Years

  35. Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

    Measured: 3 Years

Timeline

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

  1. First posted18 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionSep 2016
  4. Study completionOct 2020

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
2,008 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01751906
Sponsor's protocol ID
10-392
Acronym
ABSORB-III
Status last verified
Jan 2021
First submitted
13 Dec 2012
Last updated
11 Oct 2023
Data monitoring committee
Yes

Publications

  • Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.

    PubMed 33893022

  • Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.

    PubMed 31561250

  • Kereiakes DJ, Ellis SG, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, Tan SH, Ediebah DE, Simonton C, Stone GW; ABSORB III Investigators. Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial. Circulation. 2019 Dec 3;140(23):1895-1903. doi: 10.1161/CIRCULATIONAHA.119.042584. Epub 2019 Sep 25.

    PubMed 31553222

  • Kereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J Am Coll Cardiol. 2017 Dec 12;70(23):2852-2862. doi: 10.1016/j.jacc.2017.10.010. Epub 2017 Oct 31.

    PubMed 29100702

  • Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.

    PubMed 29089314

  • Baron SJ, Lei Y, Chinnakondepalli K, Vilain K, Magnuson EA, Kereiakes DJ, Ellis SG, Stone GW, Cohen DJ; ABSORB III Investigators. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial. JACC Cardiovasc Interv. 2017 Apr 24;10(8):774-782. doi: 10.1016/j.jcin.2017.01.022.

    PubMed 28427593

  • Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.

    PubMed 26825231

  • Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.

    PubMed 26457558

  • Kereiakes DJ, Ellis SG, Popma JJ, Fitzgerald PJ, Samady H, Jones-McMeans J, Zhang Z, Cheong WF, Su X, Ben-Yehuda O, Stone GW. Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial. Am Heart J. 2015 Oct;170(4):641-651.e3. doi: 10.1016/j.ahj.2015.07.013. Epub 2015 Jul 26.

    PubMed 26386787

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 192 sites in 2 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 11 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 192 sites in United States, Australia. 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 13 Feb 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 Cardiac Death/TV-MI/ID-TLR (TLF) (time frame: 1 year). 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 NCT01751906, which also lists 9 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 11 Oct 2023.

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