Clinical trials: Bioresorbable Scaffold
Cardiovascular Diseases, Coronary Artery Disease
ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery lesions in all-day clinical practice.
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
- Trial name
- ASSURE (NCT01583608)
- Where
- 6 sites in Germany
- Volunteers
- 183 people
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Coronary Artery Lesion
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
The primary objectives of this trial are: In patients at high-risk for restenosis, To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in…
- Trial name
- Compare Absorb (NCT02486068)
- Testing
- ABSORB scaffold, Xience
- Where
- 44 sites in Belgium, Czechia and 7 more
- Volunteers
- 1,670 people
- Sponsor
- European Cardiovascular Research Center
Cardiac Allograft Vasculopathy
Safety and Efficacy of Everolimus - Eluting Bioresorbable Vascular Scaffold for Cardiac Allograft Vasculopathy
The CART Pilot study was designed to provide preliminary observations (about performance and safety) and generate hypotheses for future studies .
- Trial name
- CART (NCT02377648)
- Testing
- Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)
- Where
- 10 sites in Italy, Netherlands
- Volunteers
- 34 people
- Sponsor
- Universita di Verona
Atherosclerosis, Peripheral Vascular Disease
ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System
The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common…
- Conditions
- Atherosclerosis, Peripheral Vascular Disease, Claudication
- Trial name
- NCT01468974
- Testing
- ESPRIT BVS
- Where
- 8 sites in Austria, Belgium and 2 more
- Volunteers
- 35 people
- Sponsor
- Abbott Medical Devices
Acute Coronary Syndrome
Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction
To assess strut coverage in patients presenting an acute myocardial infarction and treated either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel group design.
- Trial name
- COVER-AMI (NCT02890589)
- Testing
- SYNERGY stent, ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)
- Where
- France
- Volunteers
- 22 people
- Sponsor
- University Hospital, Toulouse
Coronary Artery Disease
Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions
This is a prospective, open-label, multicentre, randomized, non-inferiority clinical trial to compare the safety and performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System versus Contemporary…
- Trial name
- MeRethonRCT (NCT05417893)
- Testing
- MeRes 100 Sirolimus-eluting Bioresorbable Vascular Scaffold System (BRS)
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Peripheral Arterial Disease, Critical Limb Ischemia
MOTIV Bioresorbable Scaffold in BTK Artery Disease
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of…
- Trial name
- MOTIV BVS BTK (NCT03987061)
- Testing
- MOTIV BVS
- Where
- 8 sites in Austria, Germany
- Volunteers
- 58 people
- Sponsor
- Dr. Sabrina Overhagen
Coronary Artery Disease
ABSORB PHYSIOLOGY Clinical Investigation
The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.
- Trial name
- NCT01308346
- Testing
- Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS), XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 1 people
- Sponsor
- Abbott Medical Devices
Percutaneous Transluminal Coronary Angioplasty
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.
- Trial name
- ABSORB-LONG (NCT02831205)
- Testing
- everolimus-eluting bioresorbable vascular (Absorb) scaffold, everolimus-eluting cobalt-chromium (Xience) stent
- Where
- South Korea
- Volunteers
- 800 people
- Sponsor
- Duk-Woo Park, MD
Coronary Artery Disease
DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in CTO.
Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total Occlusion (CTO) lesions in coronary arteries.
- Trial name
- DISCRETE-CTO (NCT02936011)
- Testing
- CTO PCI using Absorb Bioresorbable Vascular Scaffolds
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Belfast Health and Social Care Trust
Coronary Artery Disease
Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.
- Trial name
- ACTIV-BVS (NCT02814578)
- Testing
- Optical coherent tomography, IntraVascular UltraSound
- Where
- 3 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Young-Hak Kim, MD, PhD
Coronary Artery Disease
NeoVas Bioresorbable Coronary Scaffold First-in-Man Study
The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas…
- Trial name
- NCT02195414
- Testing
- NeoVas BCS
- Where
- 2 sites in China
- Volunteers
- 31 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Cardiovascular Disease, Myocardial Infarction
A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI.
- Conditions
- Cardiovascular Disease, Myocardial Infarction, Thrombus, Primary Angioplasty
- Trial name
- ISAR-Absorb MI (NCT01942070)
- Testing
- Bioresorbable vascular scaffold, Durable polymer everolimus-eluting metallic stent
- Where
- 2 sites in Germany
- Volunteers
- 262 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Coronary Artery Disease, Coronary Restenosis
DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold
The aim of the study is to compare angiographic outcomes following revascularization using drug-eluting balloon (DEB) versus 2nd generation drug-eluting stent (DES) in treatment of Bioresorbable Vascular Scaffold Restenosis.
- Trial name
- SMART-BRS-ISR (NCT03074305)
- Testing
- PCI for in-bioresorbable scaffold stenosis
- Where
- South Korea
- Sponsor
- Samsung Medical Center
Cardiovascular Diseases, Coronary Artery Disease
The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary Lesions
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients with complex de novo native coronary artery…
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
- Trial name
- ASSURE ROT (NCT01915420)
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Peripheral Arterial Disease, Atherosclerotic Lesion
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral…
- Conditions
- Peripheral Arterial Disease, Atherosclerotic Lesion, Lower Extremity Ischemia, Lower Extremity Claudication
- Trial name
- RESOLV I (NCT04912323)
- Testing
- Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold
- Where
- 7 sites in Austria, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
Coronary Artery Disease
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.
- Trial name
- EVERBIOII (NCT01711931)
- Testing
- Implantation of everolimus-eluting bioresorbable vascular scaffold stent, Implantation of everolimus-eluting stents, Implantation of biolimus-eluting stents
- Where
- Switzerland
- Volunteers
- 240 people
- Sponsor
- University of Freiburg
Coronary Artery Disease, Angina
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold).
- Conditions
- Coronary Artery Disease, Angina, Unstable Angina, Stable Angina
- Trial name
- NCT02468960
- Testing
- Predilatation with OPN NC balloon catheter., Predilatation with standard compliant balloon., Absorb BVS implantation.
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- SIS Medical AG