Clinical trials: Stent Restenosis
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, 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
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
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 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
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 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
Peripheral Artery Disease
Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)
The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for…
- Trial name
- TRIUMPH (NCT01099215)
- Testing
- PVS-10200
- Where
- 3 sites in France
- Volunteers
- 21 people
- Sponsor
- Shire
In-Stent Restenosis
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter.
- Trial name
- PERVIDEO I (NCT00916279)
- Testing
- Lutonix Paclitaxel-Coated Balloon
- Where
- 8 sites in Belgium, Germany and 1 more
- Volunteers
- 41 people
- Sponsor
- C. R. Bard
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
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
Coronary Disease, Coronary Artery Disease
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- NCT01171820
- Testing
- TAXUS® Liberté™, XIENCE V® EECSS
- Where
- 28 sites in Austria, France and 9 more
- Volunteers
- 324 people
- Sponsor
- Abbott Medical Devices
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
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
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
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
CVD
Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion.
- Trial name
- APORIAS (NCT01163604)
- Testing
- Argatroban, non-argatroban treated group
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Jinling Hospital, China
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
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
Coronary Artery Disease
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval 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…
- Trial name
- XVU-Phase 1 (NCT00676520)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- United States
- Volunteers
- 8,053 people
- Sponsor
- Abbott Medical Devices