Study of the Orsiro Drug Eluting Stent System

NCT01356888 | Unknown DMC

• 1 other identifier: C1004
• Study Type: interventional
• Target: 452
• Locations: 8 countries
• Sites: 24

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss

  9 months post index procedure

Study Arms (2)

Abbott Laboratories - Xience Prime DES

ACTIVE COMPARATOR

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

Biotronik - Orsiro DES

EXPERIMENTAL

Device: Percutaneous Coronary Intervention (Orsiro DES)

Interventions

Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) DEVICE

Stenting

Abbott Laboratories - Xience Prime DES

Percutaneous Coronary Intervention (Orsiro DES) DEVICE

stenting

Biotronik - Orsiro DES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (24)

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Hospital Prive Jacques Cartier Massy

Massy, 91300, France

Location

CHU - Hospital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Polyclinique les Fleurs Ollioules

Ollioules, 83192, France

Location

Heart Centre Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Heart- and Diabetescentre NRW

Bad Oeyenhausen, 32545, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Charité Campus Mitte

Berlin, 10117, Germany

Location

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Universityhospital Lübeck

Lübeck, 23538, Germany

Location

Städtische Kliniken Neuss, Lukaskrankenhaus GmbH

Neuss, 41464, Germany

Location

Klinikum Nuernberg Sued

Nuremberg, 90471, Germany

Location

Universityhospital Rostock

Rostock, 18057, Germany

Location

Heart centre Semmelweis University

Budapest, 1122, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

OLVG (Onze Lieve Vrouwe Gasthuis)

Amsterdam, 1091, Netherlands

Location

Hospital Clínico y Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Madrid, 28222, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, 41007, Spain

Location

Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

Location

University Hospital of Bern (Inselspital)

Bern, 3010, Switzerland

Location

University Hospital of Fribourg

Fribourg, 1708, Switzerland

Location

University Hospital of Geneva

Geneva, 1211, Switzerland

Location

Cantone Hospital of Lucerne

Lucerne, 6000, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 29798778 RESULT

• 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.

  PMID: 39761745 DERIVED

• 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.

  PMID: 37062047 DERIVED

• 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.

  PMID: 35212802 DERIVED

• 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.

  PMID: 34056911 DERIVED

• 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.

  PMID: 32895004 DERIVED

• 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.

  PMID: 32890442 DERIVED

• 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.

  PMID: 25634905 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Stephan Windecker, MD

  University Hospital (Inselspital) / Bern / Switzerland

  PRINCIPAL INVESTIGATOR

• Thierry Lefèvre, MD

  Institute Hospitalier Jaques Cartier / Massy / France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); FR (3); LA (1); HU (1); DE (9); ES (3); CH (5); AU (1)