Clinical trials: Restenosis
Coronary Restenosis
SELUTION SLR™ 014 In-stent Restenosis
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will…
- Trial name
- SELUTION4ISR (NCT04280029)
- Testing
- SELUTION SLR 014 DEB, Standard of Care
- Where
- 48 sites in United States, Belgium and 5 more
- Volunteers
- 418 people
- Sponsor
- M.A. Med Alliance S.A.
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in…
- Trial name
- AGENT IDE (NCT04647253)
- Testing
- AGENT DCB, PTCA balloon catheter
- Where
- 40 sites in United States
- Volunteers
- 600 people
- Sponsor
- Boston Scientific Corporation
In-stent Restenosis
CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.
- Trial name
- NCT05731700
- Testing
- Drug Eluting Balloon
- Where
- 9 sites in France, Georgia and 2 more
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Coronary Stenosis, Coronary Artery Stenosis
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- NCT05509296
- Testing
- SINOMED CBC, NSE Coronary Dilatation Catheter
- Where
- 8 sites in China
- Volunteers
- 136 people
- Sponsor
- Sino Medical Sciences Technology Inc.
Percutaneous Coronary Intervention, Optical Coherence Tomography
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
BACKGROUD: Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.
- Conditions
- Percutaneous Coronary Intervention, Optical Coherence Tomography, In-stent Coronary Artery Restenosis
- Trial name
- SOLEMN (NCT03474432)
- Testing
- Optical Coherence Tomography
- Where
- 13 sites in United States
- Volunteers
- 12 people
- Sponsor
- Jesse Brown VA Medical Center
Coronary Stenosis, Coronary Artery Stenosis
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- EXPANSE-PTCA (NCT04985773)
- Testing
- Lacrosse NSE ALPHA coronary dilatation catheter
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Infraredx
Chronic Total Occlusion of Coronary Artery, Vascular Disease
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-AV DAPT (NCT01106534)
- Testing
- clopidogrel + aspirin OR prasugrel + aspirin, XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
- Where
- 144 sites in United States
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
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
de Novo or Restenosis Lesions
MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)
MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: A mounted Cobalt Chromium (CoCr) alloy based stent A Rapid Exchange (RX) Coronary System Delivery System A Poly…
- Trial name
- JNIR (NCT02828917)
- Testing
- MedJ-01 Ridaforolimus Eluting Coronary Stent System
- Where
- Japan
- Volunteers
- 104 people
- Sponsor
- Medinol Ltd.
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
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard
Femoropopliteal In-stent Restenosis
JetStream Atherectomy for the Treatment of In-stent Restenosis
The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic…
- Trial name
- JET-ISR (NCT02730234)
- Testing
- JetStream XC with balloon angioplasty
- Where
- 13 sites in United States
- Volunteers
- 60 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Coronary Artery Disease, Coronary Artery Stenosis
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02229864
- Testing
- Coronary artery stenting: Absorb BVS
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Myocardial Ischemia
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart…
- Trial name
- ABSORB JAPAN (NCT01844284)
- Testing
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Where
- 39 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Angioplasty, Cardiovascular Disease
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease
- Trial name
- XP China SAS (NCT01894152)
- Testing
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,002 people
- Sponsor
- Abbott Medical Devices
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeVA (NCT02790606)
- Testing
- Covera(TM) Vascular Covered Stent
- Where
- 16 sites in United States
- Volunteers
- 110 people
- Sponsor
- C. R. Bard
Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease
EXCEL Clinical Trial
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with…
- Conditions
- Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease
- Trial name
- EXCEL (NCT01205776)
- Testing
- Percutaneous Coronary Intervention, CABG
- Where
- United States
- Volunteers
- 1,905 people
- Sponsor
- Abbott Medical Devices
Restenosis, Peripheral Vascular Disease
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone.
- Trial name
- JetStreamISR (NCT01722877)
- Testing
- JetStream Navitus
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Midwest Cardiovascular Research Foundation
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
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to…
- Trial name
- ABSORB II (NCT01425281)
- Testing
- Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- Belgium
- Volunteers
- 501 people
- Sponsor
- Abbott Medical Devices