Clinical trials: In-stent Restenosis
Coronary Stenosis
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions
The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple…
- Trial name
- NCT00301522
- Testing
- TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation, Express2
- Where
- 72 sites in United States
- Volunteers
- 1,108 people
- Sponsor
- Boston Scientific Corporation
Restenosis
FLUENCY® PLUS Endovascular Stent Graft for In-stent Restenosis
The primary purpose of this study is to demonstrate that the FLUENCY® PLUS Endovascular Stent Graft can effectively and safely treat in-stent restenotic lesions in the venous outflow of the Arteriovenous (AV) access circuit of…
- Trial name
- RESCUE (NCT01257438)
- Testing
- Fluency Plus Endovascular Stent Graft, Percutaneous Transluminal Angioplasty only
- Where
- 23 sites in United States
- Volunteers
- 275 people
- Sponsor
- C. R. Bard
Coronary Artery Disease
Virtue® SAB in the Treatment of Coronary ISR Trial
A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the…
- Trial name
- NCT07045194
- Testing
- Virtue Sirolimus AngioInfusion Balloon, AGENT™ Paclitaxel Drug-Coated Balloon
- Where
- 22 sites in United States
- Volunteers
- 740 people
- Sponsor
- Orchestra BioMed, Inc
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.
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
Coronary Restenosis
Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following…
- Trial name
- SNAPIST-III (NCT00124943)
- Testing
- Nanoparticle Paclitaxel
- Volunteers
- 112 people
- Sponsor
- Celgene Corporation
Coronary Artery Disease
Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery
The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.
- Trial name
- NCT00777842
- Testing
- GTX™ Drug Eluting Coronary Stent System
- Where
- Germany
- Volunteers
- 19 people
- Sponsor
- Cook Group Incorporated
Stable Angina, Ischemic Heart Disease Silent
A Randomized Clinical Evaluation of the BioFreedom™ Stent
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and…
- Conditions
- Stable Angina, Ischemic Heart Disease Silent, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction, In-stent Coronary Artery Restenosis
- Trial name
- Leaders Free (NCT01623180)
- Testing
- Biofreedom™ Drug Coated Stent (DCS), Gazelle™ Bare Metal Coronary Stent (BMS)
- Where
- Switzerland
- Volunteers
- 2,456 people
- Sponsor
- Biosensors Europe SA
Peripheral Arterial Disease
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in…
- Trial name
- ILLUMENATE (NCT01927068)
- Testing
- Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Where
- 44 sites in Australia, Austria and 8 more
- Volunteers
- 499 people
- Sponsor
- Spectranetics Corporation
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, In Stent Restenosis
Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis
This is a prospective, multicenter, randomized controlled clinical trial, which plans to enroll 260 subjects.
- Trial name
- SIBLINT ISR (NCT04240444)
- Testing
- drug-coated balloon Catheter
- Where
- 16 sites in China
- Volunteers
- 260 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
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 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.
Coronary Restenosis
Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period
Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent…
- Trial name
- XERES (NCT00882219)
- Testing
- Xience V®
- Where
- France
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Instent Restenosis
The Valentines Trial
The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up.
- Trial name
- NCT01066832
- Testing
- Paclitaxel
- Where
- 3 sites in Germany, Italy and 1 more
- Volunteers
- 276 people
- Sponsor
- Eurocor GmbH
Coronary Artery Stenosis
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare…
- Trial name
- BLAST (NCT00739466)
- Testing
- Liposomal Alendronate
- Where
- 12 sites in Israel
- Volunteers
- 226 people
- Sponsor
- BIOrest Ltd.
In-stent Coronary Artery Restenosis
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
- Trial name
- PEPPER (NCT00961181)
- Testing
- Paclitaxel Releasing Balloon
- Where
- Germany
- Volunteers
- 81 people
- Sponsor
- Biotronik AG
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.
Coronary Artery Disease
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion…
- Trial name
- NCT00232804
- Testing
- Bx Cypher stent
- Where
- France
- Volunteers
- 639 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease, Arterial Occlusive Diseases
The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions
To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in…
- Conditions
- Coronary Artery Disease, Arterial Occlusive Diseases, Coronary Disease, Coronary Arteriosclerosis
- Trial name
- ENDEAVOR II (NCT00614848)
- Testing
- Endeavor drug eluting coronary stent
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Medtronic Vascular