Clinical trials: In-Stent Restenosis
Restenosis
Treatment of Coronary In-Stent Restenosis
The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus.
- Trial name
- TIS (NCT01735825)
- Testing
- paclitaxel-coated balloon catheter with Iopromide coating, drug eluting stent with everolimus, seal-wing paclitaxel-eluting balloon catheter
- Where
- Czechia
- Volunteers
- 199 people
- Sponsor
- University Hospital Ostrava
Percutaneous Coronary Intervention
Twelve vs 24 Months of Dual Antiplatelet Therapy in Patients With Coronary Revascularization for In-stent Restenosis
Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12…
- Trial name
- NCT02402491
- Testing
- 12 months of P2Y12 receptor antagonist, 24 months of P2Y12 receptor antagonist, Aspirin
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Beijing Anzhen Hospital
Stent Restenosis, Intimal Hyperplasia
Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions
The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs.
- Trial name
- BIOFLEX-COF (NCT03097679)
- Testing
- Pulsar Stent, LifeStent Flexstar Vascular Stent
- Where
- Austria
- Volunteers
- 86 people
- Sponsor
- Medical University of Vienna
Coronary In-stent Restenosis
Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the treatment of patients suffering from ISR after…
- Trial name
- NCT03069066
- Testing
- Bioresorbable vascular scaffold. Absorb GT1 (Abbott)
- Where
- 10 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Spanish Society of Cardiology
In-Stent Restenosis, Coronary Artery Disease
VAP-Measured Lipid Subfractions and In-Stent Restenosis After PCI
This multicenter observational study investigates whether lipid and lipoprotein subfractions measured by Vertical Auto Profile (VAP) are associated with coronary in-stent restenosis after percutaneous coronary intervention (PCI).
- Trial name
- NCT07533656
- Testing
- No intervention
- Where
- China
- Volunteers
- 3,600 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Peripheral Vascular Disease
GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis
This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L.
- Trial name
- RELINE (NCT01108861)
- Testing
- GORE VIABAHN® Endoprosthesis, Plain old balloon angioplasty
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 100 people
- Sponsor
- Flanders Medical Research Program
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
In-stent Coronary Artery Restenosis
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
This study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES).
- Trial name
- NCT01835301
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medstar Health Research Institute
Peripheral Artery Disease, In-stent Restenosis
LDD in Treatment of Femoropopliteal ISR
This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis.
- Trial name
- NCT03521843
- Testing
- balloon dilation only, balloon dilation+local drug delivery
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RenJi Hospital
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
Coronary Heart Disease, Diabetes
OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA
Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been specifically studied for Drug Eluting Stents.
- Conditions
- Coronary Heart Disease, Diabetes, Vascular Lesions, Chronic Total Occlusion of Coronary Artery
- Trial name
- OPERA (NCT01861860)
- Testing
- TAXUS™ Element long stent
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Coronary Artery Disease
Genetics Study of In-stent Restenosis
The investigators hypothesized that genetic variants of G protein influence the development of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).
- Trial name
- ISR (NCT01670396)
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Shanghai Zhongshan Hospital
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
PCI, In-stent Restenosis
Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR
This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.
- Conditions
- PCI, In-stent Restenosis, Intravascular Imaging Device
- Trial name
- NCT07297641
- Testing
- percutaneous coronary intervention
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Coronary Artery Disease
Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm)
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.
- Trial name
- RETO 320 (NCT03737565)
- Testing
- Optimax stent®
- Where
- 5 sites in Spain
- Volunteers
- 350 people
- Sponsor
- Fundación EPIC
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
Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents
Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR).
- Trial name
- NCT02528474
- Testing
- balloon angioplasty with Pantera Lux, balloon angioplasty with SeQuent Please
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Yonsei University
In-stent Restenosis
RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)
Treatment of patients with drug-eluting stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients…
- Trial name
- RIBS IV (NCT01239940)
- Testing
- Coronary angioplasty using the paclitaxel-eluting balloon, Coronary angioplasty using the Everolimus-eluting stent
- Where
- 25 sites in Spain
- Volunteers
- 310 people
- Sponsor
- Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
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