AzTrials
AzTrials

Coronary Artery DiseaseBIOFLOW-VNCT02389946

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

A study testing Orsiro DES and Xience DES in people with Coronary Artery Disease and Atherosclerosis, Coronary, run by Biotronik, Inc. at 92 sites in 13 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

The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Orsiro DES and Xience DES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,334 participants
Where
92 sitesin 13 countries
Study dates
May 2015to Mar 2021
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

Who may be able to join

  • Subject is ≥18 years or the minimum age required for legal adult consent in the country of enrollment.
  • Subject is an acceptable candidate for PCI.
  • Subject is an acceptable candidate for CABG.
  • Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
  • Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, ticagrelor or ticlopidine.
  • Subject has provided written informed consent.
Show all 16Show fewer
  • Subject is willing to comply with study follow-up requirements.
  • Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial:
  • Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel).
  • Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
  • Target lesion must be in major coronary artery or branch (target vessel).
  • Target lesion must have angiographic evidence of ≥ 50% and < 100% stenosis (by operator visual estimate). If the target lesion is < 70% stenosed, clinical evidence of ischemia by positive functional study, CT, electrocardiography, FFR, or post infarct angina.
  • TIMI flow > 1.
  • Target lesion must be ≤ 36 mm in length by operator visual estimate.
  • Target vessel RVD of 2.25-4.0 mm by operator visual estimate.
  • Target lesion must be treatable with a maximum of two overlapping stents.

Who cannot join

  • Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
  • Subject is hemodynamically unstable.
  • Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
  • Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus.
  • Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure.
  • Planned treatment of a lesion not meeting angiographic inclusion and exclusion criteria during the index procedure or after the index procedure.
Show all 29Show fewer
  • Planned surgery within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
  • History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
  • Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
  • Subject will refuse blood transfusions.
  • Subject has documented left ventricular ejection fraction (LVEF) < 30% within 90 days prior to the index procedure.
  • Subject is dialysis-dependent.
  • Subject has impaired renal function (i.e., blood creatinine > 2.5 mg/dL or 221 μmol/L determined within 7 days prior to the index procedure).
  • Subject has leukopenia (i.e. < 3,000 white blood cells/mm3), thrombocytopenia (i.e. < 100,000 platelets/mm3) or thrombocytosis (i.e. > 700,000 platelet/mm3).
  • Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).
  • Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
  • Subject has life expectancy of < 1 year.
  • Subject is participating in another investigational (medical device or drug) clinical study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
  • In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
  • Subjects will be excluded from the trial if any of the target lesions/vessels meets any of the following angiographic criteria:
  • Target lesion is located within a saphenous vein graft or arterial graft.
  • Target lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).
  • Target lesion has any of the following characteristics:
  • Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
  • Involves a side branch of > 2.0 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.
  • Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
  • Target vessel has angiographic evidence of thrombus.
  • Target lesion is totally occluded (100% stenosis).
  • Target vessel was treated with brachytherapy any time prior to the index procedure.

Trial locations and contacts

92 sites in 13 countries.

92 sites in 13 countries

United States55 sites

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Baltimore, Maryland, 21218

  • Study site

    Bay City, Michigan, 48708

  • Study site

    Boston, Massachusetts, 02120

  • Study site

    Butler, Pennsylvania, 16001

  • Study site

    Charleston, West Virginia, 25304

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44111

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Concord, California, 94520

  • Study site

    Dallas, Texas, 75226

  • Study site

    Detroit, Michigan, 48236

  • Study site

    Elyria, Ohio, 44035

  • Study site

    Fairhope, Alabama, 36535

  • Study site

    Fargo, North Dakota, 58102

  • Study site

    Fort Wayne, Indiana, 46845

  • Study site

    Greensboro, North Carolina, 27401

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77030

  • Study site

    Knoxville, Tennessee, 37934

  • Study site

    La Mesa, California, 91942

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lansing, Michigan, 48912

  • Study site

    McKinney, Texas, 75069

  • Study site

    Mechanicsburg, Pennsylvania, 17050

  • Study site

    Minneapolis, Minnesota, 55407

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Neptune City, New Jersey, 07753

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Newark, New Jersey, 07102

  • Study site

    Omaha, Nebraska, 68124

  • Study site

    Orlando, Florida, 32803

  • Study site

    Pontiac, Michigan, 48341

  • Study site

    Portland, Oregon, 97225

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Rochester, Michigan, 48307

  • Study site

    Rock Hill, South Carolina, 29732

  • Study site

    Tampa, Florida, 33613

  • Study site

    Toledo, Ohio, 43606

  • Study site

    Toledo, Ohio, 43608

  • Study site

    Troy, Michigan, 48085

  • Study site

    Tyler, Texas, 75701

  • Study site

    Urbana, Illinois, 61801

  • Study site

    Virginia Beach, Virginia, 23454

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Wynnewood, Pennsylvania, 19096

  • Study site

    York, Pennsylvania, 17403

  • Study site

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany6 sites

  • Study site

    Bad Segeberg, 23795

  • Study site

    Berlin, 10249

  • Study site

    Berlin, 10967

  • Study site

    Hamburg, 20246

  • Study site

    Minden, 32429

  • Study site

    Neuss, 41464

Other trials in Germany

Israel5 sites

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 91120

  • Study site

    Petah Tikva, 49101

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 64239

Other trials in Israel

South Korea5 sites

  • Study site

    Daegu, 705-718

  • Study site

    Gwangju, 501-757

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 135-720

  • Study site

    Seoul, 137-701

Other trials in South Korea

Spain5 sites

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08907

  • Study site

    Madrid, 28222

  • Study site

    Málaga, 29010

  • Study site

    Seville, 41071

Other trials in Spain

Belgium3 sites

  • Study site

    Genk, 3600

  • Study site

    Leuven, 3000

  • Study site

    Roeselare, 8800

Other trials in Belgium

Hungary3 sites

  • Study site

    Budapest, 1085

  • Study site

    Pécs, 7624

  • Study site

    Szeged, 6720

Other trials in Hungary

Netherlands3 sites

  • Study site

    Breda, 4818 CK

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Nieuwegein, 3435 CM

Other trials in Netherlands

Switzerland3 sites

  • Study site

    Lausanne, 1011

  • Study site

    Zurich, 8063

  • Study site

    Zurich, 8091

Other trials in Switzerland

Australia1 site

  • Study site

    Adelaide, SA 5011

Other trials in Australia

Canada1 site

  • Study site

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

Denmark1 site

  • Study site

    Aarhus, 8200

Other trials in Denmark

New Zealand1 site

  • Study site

    Auckland, 1142

Other trials in New Zealand

About this study

Official title: BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V

The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.

Read the detailed description

The BIOTRONIK BIOFLOW-V clinical trial is a prospective, multicenter, randomized, controlled trial combining data on the randomized subjects with data from two historical studies by employing a Bayesian approach.

Subjects with CAD that qualify for PCI with stenting will be screened per the protocol inclusion and exclusion criteria to achieve a total of up to 1,400 randomized subjects. Eligible subjects will be randomized in a 2:1 ratio, stratified by study center, to undergo percutaneous coronary revascularization with either the Orsiro Sirolimus Eluting Stent System (treatment group) or the Xience Everolimus Eluting Stent System (control group).

Subjects may receive treatment of up to three target lesions, one or two target lesions per target vessel, for a maximum of two target vessels. The target lesion(s) must be de novo or restenotic lesion(s) of ≤ 36 mm in length in native coronary artery(ies), with a reference vessel diameter of 2.25-4.0 mm. Treatment of restenotic lesions is allowed provided that the target lesion was previously treated with PTCA only. All treatment with study stents is to be performed during a single index procedure. Note: Concurrent treatment of non-target lesions during the index procedure is not allowed.

Randomized subjects will have clinical follow-up at 1 month, 6 months, 12 months and at 2, 3, 4 and 5 years following the index procedure.

To assess the non-inferiority of the Orsiro stent compared to the Xience stent, BIOFLOW-V randomized subjects will be combined with historical subjects from the BIOFLOW-II and BIOFLOW-IV randomized trials employing a Bayesian approach. Only subjects who meet all clinical and angiographic eligibility criteria of the BIOFLOW-V trial will be included in the analysis.

Being tested
Orsiro DES, Xience DES
Keywords
Drug eluting coronary stents, Sirolimus, Bioabsorbable polymer, DES
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Angina Pectoris

What participants receive

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

  • Orsiro DESDevice

    Also called Orsiro sirolimus coronary stent system

    Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.

  • Xience DESDevice

    Also called Xience everolimus coronary stent system

Study groups in NCT02389946
Study groupRoleWhat they receive
Orsiro sirolimus coronary stent systemExperimentalIntervention with a Orsiro DES.
Receives: Device: Orsiro DES
Xience everolimus coronary stent systemActive comparatorIntervention with a Xience DES.
Receives: Device: Xience DES

What is being measured

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

  1. Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation

    TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).

    Measured: 12-Months

Secondary outcomes (9)

  1. Number of Lesions With Device Success

    Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only.

    Measured: Hospital Discharge (6-24 hours post-index procedure)

  2. Number of Lesions With Lesion Success

    Defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method.

    Measured: Hospital Discharge (6-24 hours post-index procedure)

  3. Number of Participants With Procedure Success

    Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).

    Measured: Hospital Discharge (6-24 hours post-index procedure)

  4. Number of Participants With Myocardial Infarction

    Measured: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years

  5. Number of Participants With Myocardial Infarction or Cardiac Death

    Measured: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years

  6. Number of Participants With MACE and Individual MACE Components

    MACE events are defined as all-cause death, Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any MACE event is provided, as well as number of participants with each of the individual components.

    Measured: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years

  7. Number of Participants With TLF and Individual TLF Components

    TLF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any TLF event is provided, as well as number of participants with each of the individual components.

    Measured: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years

  8. Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components

    TVF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TVR. The number of participants with any TVF event is provided, as well as number of participants with each of the individual components.

    Measured: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years

  9. Number of Participants With Stent Thrombosis

    Stent thrombosis according to the Academic Research Consortium criteria.

    Measured: 24 hours, 30 days, 1 year, and 5 years post-index procedure

Timeline

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

  1. First posted17 Mar 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionApr 2017
  4. Study completionMar 2021

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
Outcomes assessor
Enrolment
1,334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02389946
Sponsor's protocol ID
BIOFLOW-V
Acronym
BIOFLOW-V
Status last verified
Aug 2022
First submitted
2 Mar 2015
Last updated
3 Aug 2022
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Doros G, Massaro JM, Kandzari DE, Waksman R, Koolen JJ, Cutlip DE, Mauri L. Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach. Am Heart J. 2017 Nov;193:35-45. doi: 10.1016/j.ahj.2017.08.001. Epub 2017 Aug 5.

    PubMed 29129253

  • Kandzari DE, Mauri L, Koolen JJ, Massaro JM, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R; BIOFLOW V Investigators. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017 Oct 21;390(10105):1843-1852. doi: 10.1016/S0140-6736(17)32249-3. Epub 2017 Aug 26.

    PubMed 28851504

  • Kandzari DE, Koolen JJ, Doros G, Massaro JJ, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R; BIOFLOW V Investigators. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin Durable Polymer Everolimus-Eluting Stents. J Am Coll Cardiol. 2018 Dec 25;72(25):3287-3297. doi: 10.1016/j.jacc.2018.09.019. Epub 2018 Sep 23.

    PubMed 30257191

  • Roguin A, Kandzari DE, Marcusohn E, Koolen JJ, Doros G, Massaro JM, Garcia-Garcia HM, Bennett J, Gharib EG, Cutlip DE, Waksman R. Subgroup Analysis Comparing Ultrathin, Bioresorbable Polymer Sirolimus-Eluting Stents Versus Thin, Durable Polymer Everolimus-Eluting Stents in Acute Coronary Syndrome Patients. Circ Cardiovasc Interv. 2018 Oct;11(10):e007331. doi: 10.1161/CIRCINTERVENTIONS.118.007331.

    PubMed 30354631

  • Mankerious N, Toelg R, Abdelghani M, Garcia-Garcia HM, Farhan S, Allali A, Windecker S, Lefevre T, Saito S, Kandzari DE, Waksman R, Richardt G, Hemetsberger R. Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials. Rev Esp Cardiol (Engl Ed). 2025 Aug;78(8):682-691. doi: 10.1016/j.rec.2024.12.009. Epub 2025 Jan 4. English, Spanish.

    PubMed 39761745

  • Hemetsberger R, Mankerious N, Toelg R, Abdelghani M, Farhan S, Garcia-Garica HM, Allali A, Windecker S, Lefevre T, Saito S, Kandzari D, Waksman R, Richardt G. Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol. 2023 Sep;112(9):1278-1287. doi: 10.1007/s00392-023-02205-4. Epub 2023 Apr 16.

    PubMed 37062047

  • Hemetsberger R, Abdelghani M, Toelg R, Garcia-Garcia HM, Farhan S, Mankerious N, Elbasha K, Allali A, Windecker S, Lefevre T, Saito S, Kandzari D, Waksman R, Richardt G. Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol. 2022 Jul;111(7):795-805. doi: 10.1007/s00392-022-01994-4. Epub 2022 Feb 25.

    PubMed 35212802

  • Hemetsberger R, Abdelghani M, Toelg R, Mankerious N, Allali A, Garcia-Garcia HM, Windecker S, Lefevre T, Saito S, Slagboom T, Kandzari D, Koolen J, Waksman R, Richardt G. Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer-Generation Drug-Eluting Stents. J Am Heart Assoc. 2021 Jun 15;10(12):e019815. doi: 10.1161/JAHA.120.019815. Epub 2021 May 29.

    PubMed 34056911

  • Dan K, Garcia-Garcia HM, Kolm P, Windecker S, Saito S, Kandzari DE, Waksman R. Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circ Cardiovasc Interv. 2020 Sep;13(9):e009189. doi: 10.1161/CIRCINTERVENTIONS.120.009189. Epub 2020 Sep 8.

    PubMed 32895004

  • Toelg R, Slagboom T, Waltenberger J, Lefevre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.

    PubMed 32890442

  • Kandzari DE, Koolen JJ, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R; BIOFLOW V Investigators. Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial. JACC Cardiovasc Interv. 2020 Jun 8;13(11):1343-1353. doi: 10.1016/j.jcin.2020.02.019.

    PubMed 32499026

  • Mattke S, Hanson M, Bentele M, Kandzari DE. Cost and Mortality Implications of Lower Event Rates After Implantation of an Ultrathin-Strut Coronary Stent Compared With a Thin-Strut Stent Over Four Years. Cardiovasc Revasc Med. 2020 Jul;21(7):835-842. doi: 10.1016/j.carrev.2019.12.018. Epub 2019 Dec 18.

    PubMed 31954661

  • Mattke S, Hanson M, Dallmann AC, Bentele M. Health Economic Evaluation of an Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable-Polymer Everolimus-Eluting Stent. Cardiovasc Revasc Med. 2019 Sep;20(9):752-757. doi: 10.1016/j.carrev.2018.11.006. Epub 2018 Nov 20.

    PubMed 30638888

Questions about this trial

What is this clinical trial studying?

A study testing Orsiro DES and Xience DES in people with Coronary Artery Disease and Atherosclerosis, Coronary, run by Biotronik, Inc. at 92 sites in 13 countries.

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

Who may be eligible to take part?

The sponsor lists 16 inclusion and 29 exclusion criteria. 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Germany, Israel, South Korea, Spain and 8 more countries. 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 1 Aug 2019). 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?

Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation (time frame: 12-Months). 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 NCT02389946, which also lists 13 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 3 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in