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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abbott Laboratories - Xience Prime DES | Active Comparator |
| |
| Biotronik - Orsiro DES | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) | Device | Stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss | 9 months post index procedure |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Windecker, MD | University Hospital (Inselspital) / Bern / Switzerland | Principal Investigator |
| Thierry Lefèvre, MD | Institute Hospitalier Jaques Cartier / Massy / France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Wels-Grieskirchen | Wels | Upper Austria | 4600 | Austria | ||
| Hospital Prive Jacques Cartier Massy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29798778 | Result | 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. | |
| 39761745 |
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| Percutaneous Coronary Intervention (Orsiro DES) | Device | stenting |
|
| Massy |
| 91300 |
| France |
| CHU - Hospital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Polyclinique les Fleurs Ollioules | Ollioules | 83192 | France |
| Heart Centre Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Heart- and Diabetescentre NRW | Bad Oeyenhausen | 32545 | Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
| Charité Campus Mitte | Berlin | 10117 | Germany |
| Charité Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Universityhospital Lübeck | Lübeck | 23538 | Germany |
| Städtische Kliniken Neuss, Lukaskrankenhaus GmbH | Neuss | 41464 | Germany |
| Klinikum Nuernberg Sued | Nuremberg | 90471 | Germany |
| Universityhospital Rostock | Rostock | 18057 | Germany |
| Heart centre Semmelweis University | Budapest | 1122 | Hungary |
| Pauls Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| OLVG (Onze Lieve Vrouwe Gasthuis) | Amsterdam | 1091 | Netherlands |
| Hospital Clínico y Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Puerta de Hierro de Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Virgen de la Macarena | Seville | 41007 | Spain |
| Cardiocentro Ticino | Lugano | Canton Ticino | 6900 | Switzerland |
| University Hospital of Bern (Inselspital) | Bern | 3010 | Switzerland |
| University Hospital of Fribourg | Fribourg | 1708 | Switzerland |
| University Hospital of Geneva | Geneva | 1211 | Switzerland |
| Cantone Hospital of Lucerne | Lucerne | 6000 | Switzerland |
| Derived |
| 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. |
| 37062047 | 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. |
| 35212802 | 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. |
| 34056911 | 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. |
| 32895004 | 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. |
| 32890442 | 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. |
| 25634905 | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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