Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abbott Laboratories Xience | Active Comparator | Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES). |
|
| Biotronik Orsiro | Experimental | Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott Laboratories Xience | Device |
| ||
| Biotronik Orsiro |
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure | 12 months post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinically-driven target lesion revascularization (TLR) | 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year | |
| Rate of clinically-driven target vessel revascularization (TVR) | 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shigeru Saito, MD | Okinawa Tokushukai Shonan Kamakura General Hospital | Principal Investigator |
| Ton Slagboom, MD | Onze Lieve Vrouwe Gasthuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fiona Stanley Hospital | Murdoch | 6961 | Australia | |||
| Prince of Wales Hospital Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39761745 | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR | 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year |
| Sydney |
| NSW 2031 |
| Australia |
| Gasthuisberg Leuven | Leuven | 3000 | Belgium |
| AZ Delta, H. Hart Roeselare | Roeselare | 8800 | Belgium |
| Roskilde Sygehus Nord | Roskilde | 4000 | Denmark |
| Universitäts-Herzzentrum Freiburg Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Herz- und Diabeteszentrum NRW - Kardiologische Klinik | Bad Oeynhausen | 32545 | Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
| Charite Campus Mitte - Med. klinik für Kardiologie | Berlin | 10117 | Germany |
| Universitätsklinik Bonn | Bonn | 53105 | Germany |
| Amper Kliniken AG | Dachau | 85221 | Germany |
| Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie | Hanover | 30625 | Germany |
| Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued | Nuremberg | 90471 | Germany |
| Rambam Health Corporation, Rambam Medical Center, Batgalim | Haifa | 31096 | Israel |
| Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah | Jerusalem | 91120 | Israel |
| Clalit Health Services, Rabin Medical Center, Cardiology | Petah Tikva | 49100 | Israel |
| Tenjinkai Shinkoga Hospital | Fukuoka | Japan |
| Akanekai Tsuchiya General Hospital | Hiroshima | Japan |
| Hospital Hakodate | Hokkaido | Japan |
| Sakurakai Takahashi Hospital | Hyōgo | Japan |
| Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital | Kanagawa | Japan |
| Okinawa Tokushukai Shonan Kamakura General Hospital | Kanagawa | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Kanagawa | Japan |
| Japan Organization of Occupational Health and Safety Kansai Rosai Hospital | Kumamoto | Japan |
| Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital | Kumamoto | Japan |
| Toho University Ohashi Medical Center | Tokyo | Japan |
| Tokai University Hachioji Hospital | Tokyo | Japan |
| Onze Lieve Vrouwe Gasthuis (OLVG) | Amsterdam | 1091 AC | Netherlands |
| Tergooi Blaricum | Blaricum | 1262 AN | Netherlands |
| Amphia Hospital | Breda | 4818 CK | Netherlands |
| Isala Klinieken | Zwolle | 8025 AB | Netherlands |
| Cardiology Department, Christchurch Hospital | Christchurch | 4710 | New Zealand |
| University Hospital Krakow | Krakow | 31-501 | Poland |
| Miedziowe Centrum Zdrowia SA | Lubin | 59-300 | Poland |
| Clinical Hospital Medical University Poznan | Poznan | 61-848 | Poland |
| General Cardiology & Haemodynamics Dept., Institute of Cardiology | Warsaw | 04-628 | Poland |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Clínico y Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Virgen de la Macarena | Seville | 41071 | Spain |
| Universitetssjukhuset Örebro | Oerebrö | 70185 | Sweden |
| Akademiska Sjukhuset | Uppsala | 75185 | Sweden |
| University Hospital Lausanne | Lausanne | 1011 | Switzerland |
| CardioCentro Ticino | Lugano | 6900 | Switzerland |
| University Hospital Zürich | Zurich | 8091 | Switzerland |
| 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. |
| 31235458 | Derived | Saito S, Toelg R, Witzenbichler B, Haude M, Masotti M, Salmeron R, Witkowski A, Uematsu M, Takahashi A, Waksman R, Slagboom T. BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months. EuroIntervention. 2019 Dec 6;15(11):e1006-e1013. doi: 10.4244/EIJ-D-18-01214. |
| 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 |
Not provided
Not provided