Clinical trials: Bioresorbable Scaffold
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
Vulnerable Plaque
Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold
The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS)…
- Trial name
- NCT02319733
- Testing
- Bioresorbable vascular scaffold
- Where
- Netherlands
- Volunteers
- 1 people
- Sponsor
- Canisius-Wilhelmina Hospital
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 Disease
Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion
The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy…
- Trial name
- SCORE-CTO (NCT02739685)
- Testing
- Everolimus-eluting bioresorbable vascular scaffold, Everolimus-eluting stent
- Where
- Germany
- Volunteers
- 17 people
- Sponsor
- University of Luebeck
ST Elevation Acute Myocardial Infarction
Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction
Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).
- Trial name
- NCT02151929
- Testing
- Bioresorbable vascular scaffold, Everolimus eluting stent
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- San Giuseppe Moscati Hospital
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
Arterial Occlusive Diseases, Cardiovascular Diseases
IRIS-BVS AMI Registry
The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug eluting stents) DES.
- Conditions
- Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- IRIS BVS AMI (NCT02699671)
- Testing
- Bioresorbable Vascular Scaffold
- Where
- South Korea
- Volunteers
- 69 people
- Sponsor
- Duk-Woo Park, MD
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure
Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may…
- Trial name
- PERFECTRESTORE (NCT06919562)
- Testing
- Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging
- Where
- Netherlands
- Volunteers
- 117 people
- Sponsor
- Albert Schweitzer Ziekenhuis, Netherlands
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.
Angina Pectoris, Variant
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease
The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.
- Trial name
- BIVA-pilot (NCT02932553)
- Testing
- BVS+OMT
- Where
- South Korea
- Sponsor
- Seung-Jung Park
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
Coronary Artery Stenosis
Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery…
- Trial name
- GABI-R (NCT02066623)
- Testing
- ABSORB Scaffold
- Where
- 81 sites in Austria, Germany
- Volunteers
- 3,330 people
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Coronary In-stnent Restenosis
Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis
The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge.
- Trial name
- RIBS VII (NCT03167424)
- Testing
- Treatment of restenosis
- Where
- 10 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Spanish Society of Cardiology
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
STEMI, Cardiovascular Disease
Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study
The study will assess the safety and performance of the Fantom sirolimus eluting bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.This is a…
- Conditions
- STEMI, Cardiovascular Disease, Bioresorbable Scaffold
- Trial name
- FANTOM STEMI (NCT03785431)
- Testing
- PCI with Phantom Bioresorbable Scaffold
- Where
- Poland
- Volunteers
- 20 people
- Sponsor
- Medical University of Warsaw