Clinical trials: Bioresorbable Scaffold
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.
Myocardial Infarction, Coronary Artery Disease
Coronary Artery Healing and Bioresorbable Scaffold
To compare coronary healing after optical coherence tomography guided versus conventionally angiography guided percutaneous coronary intervention with the Magmaris bioresorbable scaffold.
- Trial name
- HONEST (NCT03016624)
- Testing
- OCT guided PCI, Angiography guided PCI
- Where
- Denmark
- Volunteers
- 75 people
- Sponsor
- Odense University 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
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
A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions.
- Trial name
- NCT02796157
- Testing
- PCI with Absorb everolimus-eluting bioresorbable vascular scaffold, PCI with Xience everolimus-eluting metallic stent
- Where
- South Korea
- Volunteers
- 950 people
- Sponsor
- Yonsei University
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
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
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
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
Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization
The study is a single-centre, randomized, active controlled, open label clinical trial. The primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately after CTO-PCI (chronic total occlusion …
- Trial name
- TIGER-BVS (NCT02211066)
- Testing
- Clopidogrel, Ticagrelor
- Where
- 2 sites in Spain
- Volunteers
- 59 people
- Sponsor
- Hospital Clinic of Barcelona
Coronary Artery Disease
The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study
Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body.
- Trial name
- BIFSORB (NCT02973529)
- Testing
- Absorb, Desolve
- Where
- 4 sites in Denmark, Latvia
- Volunteers
- 120 people
- Sponsor
- Aarhus University Hospital Skejby
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
Kawasaki Disease
Safety and Vascular Remodelling After BVS Implantation for Stenotic or Occluded Lesions in Children and Young Adults With KD.
To investigate the safety and long-term vascular remodeling after bioresorbable vascular scaffold (BVS) implantation for stenotic or occluded lesion in children or young adults with Kawasaki disease (KD).
- Trial name
- NCT02771288
- Testing
- Bioresorbable Vascular Scaffold
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- National Taiwan University Hospital
Ischemia, Peripheral Arterial Disease (PTA
The ABSORB Bioresorbable Scaffold Below the Knee (BTK) Study
ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a bioresorbable drug eluting stent in the arterial vasculature below the knee
- Conditions
- Ischemia, Peripheral Arterial Disease (PTA, Arterial Occlusive Diseases
- Trial name
- NCT02793349
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- 4 sites in Australia, Netherlands and 1 more
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- The University of New South Wales
Coronary Disease, Myocardial Infarction
DOCTOR Compare - A Study in the "DOCTOR" Series (Does Optical Coherence Tomography Optimize Revascularization?"
The purpose of this study is to compare optical coherence tomography (OCT) scans performed in the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after implantation of stents or bioresorbable…
- Conditions
- Coronary Disease, Myocardial Infarction, Atherosclerosis
- Trial name
- NCT02237456
- Testing
- Comparison of OCT scans, Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare
- Where
- 2 sites in Denmark
- Volunteers
- 11 people
- Sponsor
- Aarhus University Hospital Skejby
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.