Clinical trials: Bioresorbable Scaffold
Coronary Artery Disease
DESolve Post-Approval Study
To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
- Trial name
- NCT02013349
- Testing
- coronary intervention
- Where
- 7 sites in Germany, Italy and 1 more
- Volunteers
- 102 people
- Sponsor
- Elixir Medical Corporation
Chronic Total Occlusion of Coronary Artery, Coronary Occlusion
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01759290
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- Belgium
- Volunteers
- 1,800 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, 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.
Drug Coated Balloon, Bioresorbable Scaffold
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon [DCB] strategy with bail-out BioResorbable Scaffold [BRS] versus BRS…
- Conditions
- Drug Coated Balloon, Bioresorbable Scaffold, Percutaneous Coronary Intervention (PCI), Acute Coronary Syndrome (ACS)
- Trial name
- LNB (NCT07038408)
- Testing
- Angioplasty with DCB (bail-out BRS), Angioplasty with BRS
- Where
- Estonia
- Volunteers
- 2,256 people
- Sponsor
- Ceric Sàrl
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
Coronary Artery Disease
A First-in-Man Study of the Firesorb BVS (FUTURE-I)
This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time.
- Trial name
- FUTURE-I (NCT02659254)
- Testing
- Sirolimus Target Eluting Bioresorbable Vascular Scaffold
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease, Myocardial Ischemia
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart…
- Trial name
- ABSORB JAPAN (NCT01844284)
- Testing
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Where
- 39 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
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.
Iliac Artery Stenosis, Iliac Artery Occlusion
A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions
This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System.
- Trial name
- NCT07290101
- Testing
- Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
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 Artery Disease, Myocardial Ischemia
Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent
The purpose of this study is to evaluate the safety and feasibility of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle.
- Trial name
- MEND II (NCT02189499)
- Testing
- AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 4 sites in Colombia
- Volunteers
- 42 people
- Sponsor
- Amaranth 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.
Coronary Artery Disease
Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold
Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.
- Trial name
- BIOSOLVE-India (NCT02916485)
- Testing
- Bioresorbable scaffold
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Chronic Limb-Threatening Ischemia
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Trial name
- ELITE-BTK (NCT06071429)
- Testing
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA)
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- R3 Vascular Inc.
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
Coronary Artery Disease
Study of MeRes100 in the Treatment of Patient With Coronary Artery Disease.
This is a Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China.
- Trial name
- MeReS100-China (NCT03454724)
- Testing
- MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System, Xience EES Everolimus Eluting Coronary Stent System
- Volunteers
- 484 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.