Clinical trials: Bioresorbable Scaffold
Coronary Artery Disease
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to…
- Trial name
- ABSORB II (NCT01425281)
- Testing
- Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- Belgium
- Volunteers
- 501 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
MOTIV BTK Randomized Controlled Trial
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
- Trial name
- NCT05406622
- Testing
- MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 26 sites in United States, Germany
- Volunteers
- 292 people
- Sponsor
- REVA Medical, Inc.
Coronary Artery Disease
A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II
The FUTURE-II study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale…
- Trial name
- FUTURE-II (NCT02890160)
- Testing
- Firesorb, XIENCE
- Where
- China
- Volunteers
- 430 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Ischemic Heart Disease, Angina Pectoris
Absorb GT1 Japan PMS
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for…
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT03409731
- Testing
- ABSORB GT1 BVS
- Where
- 15 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
FANTOM Post Market Clinical Trial
Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold
- Trial name
- NCT03587922
- Testing
- Fantom
- Where
- 10 sites in Austria, Germany and 1 more
- Volunteers
- 1,500 people
- Sponsor
- REVA Medical, Inc.
Coronary Disease, Coronary Artery Disease
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB UK (NCT01977534)
- Testing
- Absorb BVS
- Where
- 24 sites in United Kingdom
- Volunteers
- 1,005 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Vascular Diseases
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
- Conditions
- Peripheral Arterial Disease, Vascular Diseases, Stenosis, Femoropopliteal Stenosis
- Trial name
- Efemoral I (NCT04584632)
- Testing
- Efemoral Vascular Scaffold System (EVSS)
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 100 people
- Sponsor
- Efemoral Medical, Inc.
Coronary Artery Disease, Myocardial Ischemia
Safety and Efficacy Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent
The purpose of this study is to evaluate the safety and performance of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle.
- Trial name
- RENASCENT (NCT02255864)
- Testing
- AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 5 sites in Italy
- Volunteers
- 21 people
- Sponsor
- Amaranth Medical Inc.
Coronary Artery Disease, Antineoplastic Agents
Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study
The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group.
- Trial name
- NCT03284255
- Testing
- study group, control group
- Where
- 25 sites in China
- Volunteers
- 431 people
- Sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.
Coronary Artery Disease
NeoVas Bioresorbable Coronary Scaffold Registry Study
The NeoVas Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center, single arm registry trial based on the NeoVas FIM study which verified the safety and effectiveness of NeoVas initially.
- Trial name
- NCT02305472
- Testing
- NeoVas BCS
- Where
- 27 sites in China
- Volunteers
- 825 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Coronary Artery Disease, Myocardial Ischemia
Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary Stent
The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle.
- Trial name
- RENASCENT II (NCT02568462)
- Testing
- AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 12 sites in Colombia, Italy
- Volunteers
- 60 people
- Sponsor
- Amaranth Medical Inc.
Coronary Artery Disease
A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
This study is a prospective, multi-center single arm registry trial, planning to enroll 785 subjects. All subjects will receive clinical follow-up at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year after index procedure.
- Trial name
- NCT04179045
- Testing
- The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
- Where
- 5 sites in China
- Volunteers
- 785 people
- Sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.
Coronary Artery Disease
Trial for MicroPort's Firesorb BVS: FUTURE-III
The FUTURE-III study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale…
- Trial name
- FUTURE-III (NCT03660202)
- Testing
- Firesorb
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease
NeoVas Bioresorbable Coronary Scaffold First-in-Man Study
The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas…
- Trial name
- NCT02195414
- Testing
- NeoVas BCS
- Where
- 2 sites in China
- Volunteers
- 31 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Coronary Artery Disease
Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)
The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
- Trial name
- FANTOM I (NCT02512003)
- Testing
- Fantom Scaffold
- Where
- 2 sites in Brazil, Poland
- Volunteers
- 7 people
- Sponsor
- REVA Medical, Inc.
Coronary Artery Disease
A Clinical Trial to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease
A prospective, multi-center, single-arm trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease.
- Trial name
- IRONMAN-III (NCT05205499)
- Testing
- Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System
- Where
- China
- Volunteers
- 1,059 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Peripheral Arterial Disease, Atherosclerotic Lesion
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral…
- Conditions
- Peripheral Arterial Disease, Atherosclerotic Lesion, Lower Extremity Ischemia, Lower Extremity Claudication
- Trial name
- RESOLV I (NCT04912323)
- Testing
- Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold
- Where
- 7 sites in Austria, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
Coronary Artery Disease, Coronary Artery Stenosis
ReZolve2 Clinical Investigation
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.
- Trial name
- RESTORE II (NCT01845311)
- Testing
- ReZolve2 Scaffold
- Where
- 3 sites in Australia, Brazil and 1 more
- Volunteers
- 89 people
- Sponsor
- REVA Medical, Inc.