Clinical trials: Bioresorbable Scaffold
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.
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.
Infrapopliteal Lesions, Critical Limb Ischemia
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with…
- Trial name
- NCT05971394
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Coronary Artery Disease
Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial
To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion…
- Trial name
- NCT02086045
- Testing
- DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
- Where
- 13 sites in Belgium, Brazil and 4 more
- Volunteers
- 126 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
- Trial name
- FANTOM II (NCT02539966)
- Testing
- Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
- Where
- 28 sites in Australia, Belgium and 6 more
- Volunteers
- 272 people
- Sponsor
- REVA Medical, Inc.
Coronary Artery Disease
Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry
This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.
- Trial name
- NCT04034121
- Testing
- DESolve Cx drug eluting coronary scaffold system
- Where
- 3 sites in Belgium, Brazil
- Volunteers
- 50 people
- Sponsor
- Elixir Medical Corporation
Acute ST Segment Elevation Myocardial Infarction
ABSORB STEMI: the TROFI II Study
This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority, European multicenter clinical trial. The primary objective of this study is to assess the neointimal healing score (as evaluated by…
- Trial name
- NCT01986803
- Testing
- Percutaneous Coronary Intervention
- Where
- 8 sites in Denmark, Netherlands and 2 more
- Volunteers
- 191 people
- Sponsor
- ECRI bv
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.
Coronary Artery Disease, Myocardial Ischemia
Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III)
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 III (NCT02900937)
- Testing
- AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 13 sites in Colombia, Italy
- Volunteers
- 70 people
- Sponsor
- Amaranth 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
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Stenosis
DESolve® X-Pand Global Post Market Registry
The X-Pand Registry is intended to facilitate analysis of acute \& long-term safety as well as treatment outcomes with DESolve in patients with CAD.
- Trial name
- X-Pand (NCT02453035)
- Testing
- PTCA - Desolve Scaffold
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 154 people
- Sponsor
- Elixir Medical Corporation
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
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.
Single Coronary Vessel Disease
A First-in-Man Study of IBS
The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS.
- Trial name
- IBS-FIM (NCT03509142)
- Testing
- Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Coronary Artery Disease, Coronary Artery Stenosis
Absorb IV Randomized Controlled Trial
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02173379
- Testing
- Absorb BVS, XIENCE
- Where
- 120 sites in United States, Australia and 3 more
- Volunteers
- 2,604 people
- Sponsor
- Abbott Medical Devices
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.
Superficial Femoral Artery Lesions, Atherosclerosis of Femoral Artery
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.
- Trial name
- STANCE (NCT01403077)
- Testing
- 480 Biomedical Bioresorbable Scaffold System
- Where
- 6 sites in Australia, Austria and 2 more
- Volunteers
- 46 people
- Sponsor
- 480 Biomedical
Myocardial Ischemia, Coronary Artery Stenosis
ABSORB EXTEND Clinical Investigation
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- ABSORB EXTEND (NCT01023789)
- Testing
- ABSORB BVS
- Where
- 56 sites in Argentina, Australia and 23 more
- Volunteers
- 812 people
- Sponsor
- Abbott Medical Devices
Atherosclerosis, Peripheral Artery Disease
The ABSORB BTK (Below The Knee) Clinical Investigation
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following…
- Conditions
- Atherosclerosis, Peripheral Artery Disease, Peripheral Vascular Disease, PAD
- Trial name
- NCT01341340
- Testing
- Everolimus Eluting BVS
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices