27 completed, 7 unknown, 6 active not recruiting, 4 terminated. 24 Not applicable, 3 Phase 4, 1 Phase 1, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 24 | Completed 13, Unknown 5, Active not recruiting 4, Suspended 1, Terminated 1 |
| Phase 4 | 3 | Completed 3 |
| Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold - Coronary Artery Disease, Atherosclerosis of Coronary Artery | Not applicable | Active not recruiting | Biotronik AG | 100 | 2025-02-18 | 2026-10-23 |
| Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First) Oscar Peripheral Multifunctional Catheter - Peripheral Arterial Disease, Peripheral Arterial Disease(PAD) | Recruiting | Biotronik AG | 200 | 2024-12-19 | 2025-01-06 | |
| Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System Freesolve RMS, Xience DES - Coronary Artery Disease, Atherosclerosis, Coronary | Not applicable | Active not recruiting | Biotronik AG | 1861 | 2024-05-13 | 2026-07-07 |
| BIOFLOW-china Post-marketing Study (BIOTRONIK) BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System - In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis | Terminated | Biotronik (Beijing) Medical Device Ltd. | 122 | 2023-06-02 | 2024-12-16 | |
| Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures Peripheral Arterial Disease | Completed | Biotronik AG | 380 | 2023-05-29 | 2024-11-01 | |
| BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions Ballon expandable stent and PTA - Peripheral Artery Disease | Active not recruiting | Biotronik AG | 160 | 2021-08-10 | 2023-12-12 | |
| BRight DCB First-in-Human Study BRight DCB - Peripheral Artery Disease | Not applicable | Completed | Biotronik CRC Inc. | 48 | 2021-02-04 | 2024-05-22 |
| Resorbable Magnesium Scaffolds Registry Magmaris, Freesolve - Coronary Artery Disease | Recruiting | Biotronik AG | 1106 | 2020-11-18 | 2025-11-21 | |
| BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry Orsiro Mission DES - Coronary Artery Disease, Myocardial Ischemia | Active not recruiting | Biotronik AG | 872 | 2020-09-25 | 2024-06-21 | |
| First in Men Study: BIOMAG-I Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold - Coronary Artery Disease | Not applicable | Active not recruiting | Biotronik AG | 116 | 2020-04-27 | 2022-07-22 |
| Retrospective Follow-up of BIOLUX P-I/-II Passeo-18, Passeo-18 Lux - Overall Mortality | Completed | Biotronik AG | 132 | 2020-02-25 | 2021-08-05 | |
| Bioflow-DAPT Study Percutaneous coronary intervention - Coronary Artery Disease | Phase 4 | Completed | Biotronik AG | 1948 | 2020-02-24 | 2024-06-07 |
| BIO REsponse Adapted Combination Therapy Pilot Study Duplex Ultrasound (DUS), IVUS with Intraarterial pressure measurement (IAP) if needed - Peripheral Arterial Disease | Not applicable | Unknown | Biotronik AG | 150 | 2018-11-09 | 2022-08-29 |
| BIOFLOW-SV All Comers Registry Orsiro Sirolimus Eluting Coronary Stent System - de Novo, Symptomatic Ischemic Heart Disease | Terminated | Biotronik AG | 261 | 2018-08-27 | 2024-02-15 | |
| BIOFLOW-SV Portugal Registry Orsiro Sirolimus Eluting Coronary Stent System - Ischemic Heart Disease | Terminated | Biotronik AG | 173 | 2018-07-05 | 2024-02-15 | |
| iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction iFR, CMR - Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease | Not applicable | Active not recruiting | Radboud University Medical Center | 1146 | 2017-12-21 | 2026-08-14 |
| Vascular Implant Safety and Efficacy Study Stent - Coronary Artery Disease | Not applicable | Completed | Biotronik CRC Inc. | 66 | 2017-08-14 | 2020-07-10 |
| Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold Bioresorbable scaffold - Coronary Artery Disease | Not applicable | Suspended | Biotronik AG | 100 | 2017-06-01 | 2017-06-14 |
| BIOLUX P-III SPAIN All-Comers Registry Passeo-18 Lux DCB - Peripheral Arterial Disease | Completed | Biotronik AG | 44 | 2017-03-22 | 2021-08-05 | |
| BIOTRONIK 4French for AMBulatory Peripheral Intervention Biotronik 4 French Portfolio, 6 French Portfolio - Peripheral Artery Disease, Access Site Complication | Completed | Biotronik AG | 821 | 2017-03-17 | 2021-04-01 |
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Coronary Artery Disease (22) · Peripheral Arterial Disease (12) · Myocardial Ischemia (7) · Angina Pectoris (5) · Acute Coronary Syndrome (4) · Atherosclerosis (4) · Arteriosclerosis (2) · Bites and Stings (2) · Constriction, Pathologic (2) · Coronary Restenosis (2) · Coronary Stenosis (2) · Vascular Diseases (2) · Angina, Stable (1) · Aortic Valve Stenosis (1) · Diabetes Mellitus (1)
Percutaneous Coronary Intervention (6) · Stents (2) · Drug Delivery Systems (1) · Ultrasonography, Doppler, Duplex (1)
Germany (31) · Switzerland (22) · Belgium (21) · Austria (16) · Netherlands (16) · Spain (14) · France (11) · Latvia (9) · Australia (8) · Hungary (7) · Italy (7) · Denmark (6) · Poland (5) · New Zealand (4) · Israel (3)
Michael Haude, MD (3) · Esther Gerteis (2) · Adnan Kastrati, MD (1) · Christoph Hehrlein, MD (1) · Christoph K Naber, MD (1) · Christoph Kaiser, Prof (1) · David Kandzari, MD (1) · Deloose Koen, Dr (1) · Dierk Scheinert, MD (1) · Flavio Luciano Ribichini, Prof. Dr. (1) · Franck Vermassen (1) · Gunnar Tepe, MD (1) · Hendrik Treede, MD (1) · Jacques Koolen, MD (1)
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