Clinical trials: Vascular Lesions
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
Coronary Artery Disease
First in Men Study: BIOMAG-I
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
- Trial name
- NCT04157153
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Austria, Belgium and 6 more
- Volunteers
- 116 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral…
- Trial name
- NCT02733653
- Testing
- Jetstream Atherectomy System
- Where
- 10 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Atherosclerosis, Coronary Artery Disease
NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions
NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)
- Trial name
- NCT01703000
- Testing
- Percutaneous coronary intervention (NG PROMUS)
- Where
- 9 sites in Australia, New Zealand and 1 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Stable Angina, Unstable Angina
International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions
The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.
- Conditions
- Stable Angina, Unstable Angina, Documented Silent Ischemia
- Trial name
- NEXT (NCT01373502)
- Testing
- DES Limus Carbostent, Taxus Liberté Stent
- Where
- 11 sites in Belgium, France and 2 more
- Volunteers
- 323 people
- Sponsor
- CID - Carbostent & Implantable Devices
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
Benign Pigmented and Vascular Lesions and Scars
755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars
Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars
- Trial name
- NCT01745627
- Testing
- 755nm Alex laser
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Cynosure, Inc.
Coronary Artery Disease
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx…
- Trial name
- RAVEL (NCT00233805)
- Testing
- Sirolimus coated Bx Velocity™, Bare metal Bx Velocity™
- Where
- France
- Volunteers
- 220 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Advanced NanoTherapies Dual-API DCB to Treat De-Novo Lesions in Patients With Symptomatic Coronary Artery Disease
This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between ≥2.0 and…
- Trial name
- ADVANCE-DCB (NCT05521542)
- Testing
- SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter
- Where
- 5 sites in Australia, Dominican Republic and 1 more
- Volunteers
- 28 people
- Sponsor
- Advanced NanoTherapies
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Bifurcation Lesion, Coronary Artery Disease
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.
- Trial name
- insProvisional (NCT03780192)
- Testing
- Inspiron Sirolimus Eluting Stent
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Artery Disease
FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent
The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW)…
- Trial name
- NCT00233818
- Testing
- Sirolimus-coated Bx VELOCITY Stent
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary Bifurcated Lesions
The purpose of this study is to evaluate the efficacy and safety of Microport sirolimus drug coated balloon catheter for the treatment of coronary bifurcation lesions.
- Trial name
- PROMISE-BIF (NCT04918615)
- Testing
- PCI
- Where
- China
- Volunteers
- 236 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm²…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB A (NCT00300131)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) >36 mm and ≤ 44 mm in length (by…
- Trial name
- BIOFLOW-48 (NCT06779630)
- Testing
- Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System
- Where
- 23 sites in United States, Austria and 4 more
- Volunteers
- 150 people
- Sponsor
- Teleflex
Angina (Stable), CAD - Coronary Artery Disease
Advanced NanoTherapies Dual-API DCB to Treat De-Novo and ISR Lesions in Patients With Symptomatic Coronary Artery Disease
The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2.
- Conditions
- Angina (Stable), CAD - Coronary Artery Disease, Unstable Angina, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- ADVANCE-DUO (NCT07368933)
- Testing
- SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Advanced NanoTherapies
Aortic Aneurysm, Thoracic, Aorta; Lesion
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation…
- Trial name
- SSB 11-02 (NCT02777593)
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 35 sites in United States
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions
TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control.
- Trial name
- NCT00371709
- Testing
- TAXUS Liberté-SR, TAXUS™ Express
- Where
- 62 sites in United States, Australia and 5 more
- Volunteers
- 871 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Coronary Restenosis
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure.
- Trial name
- NCT00248066
- Testing
- RESTEN-MP
- Where
- 3 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Sarepta Therapeutics, Inc.