Clinical trials: In-Stent Restenosis
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
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
Stenosis, Occlusion
Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
- Conditions
- Stenosis, Occlusion, Restenosis
- Trial name
- SPORTS (NCT03332264)
- Testing
- SeQuent Please OTW, Eluvia Vascular Stent System, Nitinol stent
- Where
- 10 sites in Austria, Germany
- Volunteers
- 224 people
- Sponsor
- InnoRa GmbH
Coronary Disease, Coronary Artery Disease
PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions
PROSPECT is a multi-center prospective registry of Acute Coronary Syndromes (ACS) patients with single or double vessel coronary artery disease.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- NCT00180466
- Where
- 40 sites in United States, Belgium and 10 more
- Volunteers
- 697 people
- Sponsor
- Abbott Medical Devices
Coronary In-stent Restenosis
Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
The study will evaluate the long-term safety and efficacy of intravascular beta radiation therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will be collected retrospectively on patients…
- Trial name
- NCT00852176
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Best Vascular, Inc.
Peripheral Arterial Disease
TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions
A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).
- Trial name
- NCT03306199
- Testing
- Laser Atherectomy
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
- Trial name
- INSIGHT (NCT03192696)
- Testing
- Atherectomy Catheter
- Where
- 12 sites in United States
- Volunteers
- 127 people
- Sponsor
- Avinger, Inc.
In-stent Restenosis
Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)
To demonstrate acceptable short term safety rates of the Drug-eluting Coronary Spur Stent System as a primary treatment for coronary in-stent restenosis.
- Trial name
- NCT06117150
- Testing
- Drug-eluting Coronary Spur Stent System
- Where
- 2 sites in New Zealand
- Volunteers
- 9 people
- Sponsor
- ReFlow Medical, Inc.
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