Clinical trials: Stent Restenosis
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
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
Coronary Disease
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™…
- Trial name
- NCT00165035
- Testing
- CoStar Paclitaxel Drug Eluting Coronary Stent System, TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
- Where
- 2 sites in United States
- Volunteers
- 1,701 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial
To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for…
- Trial name
- ENDEAVOR III (NCT00217256)
- Testing
- Percutaneous Coronary Stenting
- Volunteers
- 436 people
- Sponsor
- Medtronic Vascular
Peripheral Arterial Disease
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Trial name
- EXCITE ISR (NCT01330628)
- Testing
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 252 people
- Sponsor
- Spectranetics Corporation
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
Peripheral Vascular Diseases
ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
- Trial name
- NCT00180505
- Testing
- ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
- Where
- 13 sites in Austria, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France
The objective of this study is to prepare elements of response to the Haute Autorité de Santé (High Health Authority) of France, which is expecting data relating to the routine use of XIENCE V® endoprothesis within the 5 years…
- Trial name
- Far XIENCE V® (NCT00987506)
- Testing
- XIENCE V®
- Where
- 58 sites in France
- Volunteers
- 1,165 people
- Sponsor
- Abbott Medical Devices
Coronary Disease, Coronary Artery Disease
EXecutive Registry: Evaluating XIENCE V® in a Multi Vessel Disease
The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Artery Restenosis
- Trial name
- EXecutive (NCT01310309)
- Testing
- Coronary artery placement of a drug-eluting stent
- Where
- 23 sites in Italy
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients experiencing in-stent restenosis.
- Trial name
- TAXUS V ISR (NCT00287573)
- Testing
- TAXUS Express2, Brachytherapy (beta source)
- Where
- 42 sites in United States, Canada
- Volunteers
- 488 people
- Sponsor
- Boston Scientific Corporation
In-stent Restenosis, Stent Fracture
Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis
The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents.
- Conditions
- In-stent Restenosis, Stent Fracture, Stent Complication
- Trial name
- NIMBLE-I (NCT06968858)
- Testing
- NIMBLE test
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nimble Diagnostics S.L.
In-Stent Restenosis
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery…
- Trial name
- NCT00231257
- Testing
- Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent, Brachytherapy
- Where
- United States
- Volunteers
- 384 people
- Sponsor
- Cordis US Corp.
Coronary Instent Restenosis
A Safety and Efficacy Study of Paclitaxel-eluting Balloon to Paclitaxel-eluting Stent
The purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon…
- Trial name
- PEPCAD (NCT01622075)
- Testing
- SeQuent® Please, Taxus Liberte
- Where
- China
- Volunteers
- 220 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
In-stent Coronary Artery Restenosis, Coronary Artery Restenosis
Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
- Conditions
- In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis
- Trial name
- RESPECT-ISR (NCT05093244)
- Testing
- SeQuent Please ReX, Plain old balloon angioplasty (POBA)
- Sponsor
- B. Braun Medical Inc.
Stents, Coronary Artery Disease
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V®…
- Conditions
- Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis
- Trial name
- NCT00180479
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 1,002 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
The Effects of Bindarit in Preventing Stent Restenosis
The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by…
- Trial name
- NCT01269242
- Testing
- bindarit
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Coronary Artery Disease
Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR
The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO).
- Trial name
- NCT04767022
- Testing
- Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB), Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Genoss Co., Ltd.
Hyperplasia, Restenosis
Numen Stent Assessment Using OCT Technique in a Single Center Study
This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina…
- Trial name
- NAUTIC (NCT00774917)
- Testing
- Numen
- Where
- 2 sites in Austria
- Volunteers
- 60 people
- Sponsor
- International Biomedical Systems S.p.A.
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
Coronary Disease, Coronary Stenosis
Limus Eluted From A Durable Versus ERodable Stent Coating
The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.
- Trial name
- LEADERS (NCT00389220)
- Testing
- Coronary stent placement
- Where
- 10 sites in Belgium, France and 5 more
- Volunteers
- 1,707 people
- Sponsor
- Biosensors Europe SA