Clinical trials: Bioresorbable Scaffold
Cardiovascular Diseases
The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation
The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.
- Trial name
- SPARTA (NCT04501900)
- Testing
- Clopidogrel
- Volunteers
- 2,106 people
- Sponsor
- Shanghai Zhongshan Hospital
Percutaneous Coronary Intervention, Myocardial Revascularization
FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study
Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).
- Conditions
- Percutaneous Coronary Intervention, Myocardial Revascularization, Tomography, Optical Coherence
- Trial name
- NCT04591938
- Testing
- Fantom Encore Bioresorbable scaffold implantation
- Where
- 3 sites in Belgium, Netherlands
- Volunteers
- 50 people
- Sponsor
- Joost Daemen
Acute Coronary Syndromes
REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported.
- Trial name
- NCT02601404
- Testing
- Bioresorbable scaffold (BRS)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease
A Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention With Bioresorbable Vascular Scaffold
It is well-known that non-optimal stent implantation associated with under-expansion or incomplete strut apposition during percutaneous coronary intervention (PCI) leads to a higher incidence of restenosis and stent thrombosis.
- Trial name
- NCT02466282
- Testing
- Angiography-guided PCI with bioresorbable vascular scaffold, optical coherence tomography-guided PCI with bioresorbable vascular scaffold
- Where
- South Korea
- Volunteers
- 13 people
- Sponsor
- Yonsei University
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, Stents
P2Y12 Inhibitor Monotherapy Versus Extended DAPT in Patients Treated With Bioresorbable Scaffold
This study aimed to compare the efficacy and safety of P2Y12 inhibitor monotherapy versus extended dual antiplatelet therapy (DAPT) following 12-month of DAPT in patients undergoing percutaneous coronary intervention (PCI) with…
- Conditions
- Coronary Artery Disease, Stents, Atherosclerosis
- Trial name
- SMART-CHOICEII (NCT03119012)
- Testing
- Clopidogrel, Ticagrelor, Aspirin
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Samsung Medical Center
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
ST-elevation Myocardial Infarction (STEMI)
Use of BVS in ST-segment Elevation Myocardial Infarction (STEMI): the BVS STEMI STRATEGY-IT Prospective Registry
BVS STEMI STRATEGY-IT is a spontaneous, prospective, non-randomized, single-arm multicenter registry on consecutive STEMI patients eligible to undergo primary percutaneous coronary intervention (PPCI) with BVS implantation on the…
- Trial name
- STRATEGY-IT (NCT02601781)
- Testing
- Primary percutaneous coronary intervention (PPCI), Bioresorbable Vascular Scaffold (BVS ABSORB)
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Azienda Ospedaliera Bolognini di Seriate Bergamo
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.
Myocardial Ischemia
Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation
Previous studies reported 20-30% of under-expansion or malapposition with BVS, which would increase the risk of adverse events including late stent thrombosis.
- Trial name
- NCT02894697
- Testing
- Angiography-guided PCI with BVS, Optical coherence tomography-guided PCI with BVS
- Where
- South Korea
- Volunteers
- 123 people
- Sponsor
- Yonsei University
Critical Limb Ischemia
Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)
The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following…
- Trial name
- DISAPEAR (NCT02043795)
- Testing
- BVS, Abbott Vascular
- Where
- Singapore
- Volunteers
- 15 people
- Sponsor
- Changi General Hospital
Coronary Artery Disease, Ischemic Heart Disease
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Stable Angina, Unstable Angina
- Trial name
- CSI-Ulm-BVS (NCT02162056)
- Testing
- use of bioresorbable vascular scaffolds
- Where
- Germany
- Volunteers
- 326 people
- Sponsor
- University of Ulm
Angina
Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina
The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable…
- Trial name
- FEASTRU (NCT02707783)
- Testing
- Bioresorbable vascular scaffold (BVS) implantation
- Where
- 14 sites in Russia
- Volunteers
- 1,602 people
- Sponsor
- International Foundation for Development of Medical Science and Education Healthy Heart
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.
Angina Pectoris, Coronary Artery Disease
Chronic Total Coronary Occlusion Treatment Results 6 Years After Bioresorbable Scaffold Implantation
Aim of the study is to evaluate chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation by quantitative coronary analysis, intravascular ultrasound and optical coherence tomography.
- Conditions
- Angina Pectoris, Coronary Artery Disease, Occlusion, Coronary
- Trial name
- CTO_BVS (NCT06164977)
- Testing
- Percutaneous coronary intervention.
- Where
- Latvia
- Volunteers
- 34 people
- Sponsor
- Pauls Stradins Clinical University Hospital