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Coronary Artery DiseaseBIOFLOW-IINCT01356888

Study of the Orsiro Drug Eluting Stent System

A study testing Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) and Percutaneous Coronary Intervention (Orsiro DES) in people with Coronary Artery Disease, run by Biotronik AG at 24 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) and Percutaneous Coronary Intervention (Orsiro DES)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
24 sitesin 8 countries
Study dates
May 2011to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Subject has provided a written informed consent
  • Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
  • The target lesion length is ≤ 26 mm
  • The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm

Main Exclusion Criteria:

  • Evidence of myocardial infarction within 72 hours prior to index procedure
  • Unprotected left main coronary artery disease (stenosis >50%)
  • Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
  • Target lesion involves a side branch > 2.0 mm in diameter
  • Heavily calcified lesion
  • Target lesion is located in or supplied by an arterial or venous bypass graft

Trial locations and contacts

24 sites in 8 countries.

24 sites in 8 countries

Germany9 sites

  • Heart Centre Bad Krozingen

    Bad Krozingen, 79189

  • Heart- and Diabetescentre NRW

    Bad Oeyenhausen, 32545

  • Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Charité Campus Mitte

    Berlin, 10117

  • Charité Campus Benjamin Franklin

    Berlin, 12203

  • Universityhospital Lübeck

    Lübeck, 23538

  • Städtische Kliniken Neuss, Lukaskrankenhaus GmbH

    Neuss, 41464

  • Klinikum Nuernberg Sued

    Nuremberg, 90471

  • Universityhospital Rostock

    Rostock, 18057

Other trials in Germany

Switzerland5 sites

  • University Hospital of Bern (Inselspital)

    Bern, 3010

  • University Hospital of Fribourg

    Fribourg, 1708

  • University Hospital of Geneva

    Geneva, 1211

  • Cantone Hospital of Lucerne

    Lucerne, 6000

  • Cardiocentro Ticino

    Lugano, Canton Ticino, 6900

Other trials in Switzerland

France3 sites

  • Hospital Prive Jacques Cartier Massy

    Massy, 91300

  • CHU - Hospital Arnaud de Villeneuve

    Montpellier, 34295

  • Polyclinique les Fleurs Ollioules

    Ollioules, 83192

Other trials in France

Spain3 sites

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222

  • Hospital Universitario Virgen de la Macarena

    Seville, 41007

Other trials in Spain

Austria1 site

  • Klinikum Wels-Grieskirchen

    Wels, Upper Austria, 4600

Other trials in Austria

Hungary1 site

  • Heart centre Semmelweis University

    Budapest, 1122

Other trials in Hungary

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

Other trials in Latvia

Netherlands1 site

  • OLVG (Onze Lieve Vrouwe Gasthuis)

    Amsterdam, 1091

Other trials in Netherlands

About this study

Official title: BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

Being tested
Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES), Percutaneous Coronary Intervention (Orsiro DES)
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)Device

    Stenting

  • Percutaneous Coronary Intervention (Orsiro DES)Device

    stenting

Study groups in NCT01356888
Study groupRoleWhat they receive
Abbott Laboratories - Xience Prime DESActive comparatorNot described
Receives: Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
Biotronik - Orsiro DESExperimentalNot described
Receives: Device: Percutaneous Coronary Intervention (Orsiro DES)

What is being measured

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

  1. Late Lumen Loss

    Measured: 9 months 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 posted20 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJul 2013
  4. Study completionDec 2018 (estimated)

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
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01356888
Sponsor's protocol ID
C1004
Acronym
BIOFLOW-II
Status last verified
May 2018
First submitted
18 May 2011
Last updated
31 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lefevre T, Haude M, Neumann FJ, Stangl K, Skurk C, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, Macia JC, Windecker S. Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: 5-Year Outcomes of the Randomized BIOFLOW-II Trial. JACC Cardiovasc Interv. 2018 May 28;11(10):995-1002. doi: 10.1016/j.jcin.2018.04.014.

    PubMed 29798778

  • 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

  • Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T, Sabate M, Goicolea J, Barragan P, Cook S, Piot C, Richardt G, Merkely B, Schneider H, Bilger J, Erne P, Waksman R, Zaugg S, Juni P, Lefevre T. Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial. Circ Cardiovasc Interv. 2015 Feb;8(2):e001441. doi: 10.1161/CIRCINTERVENTIONS.114.001441.

    PubMed 25634905

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) and Percutaneous Coronary Intervention (Orsiro DES) in people with Coronary Artery Disease, run by Biotronik AG at 24 sites in 8 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: status not confirmed, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, Switzerland, France, Spain, Austria and 3 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?

Results are not available in the source record.

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?

Late Lumen Loss (time frame: 9 months post index procedure). 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 NCT01356888, which also lists 8 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 31 May 2018.

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