Clinical trials: In-stent Restenosis
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.
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.
Coronary Artery Disease
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patients With Coronary In-stent Restenosis
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent…
- Trial name
- NCT04405063
- Testing
- Paclitaxel Coated PTCA Balloon Catheter
- Volunteers
- 82 people
- Sponsor
- Genoss Co., Ltd.
Coronary Artery Calcification, Intravascular Lithotripsy
IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)
The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Excimer Laser-coronary Atherectomy, Stent Restenosis
- Trial name
- DRAGON (NCT06276114)
- Testing
- Stent Underexpansion
- Where
- 20 sites in Italy, Poland
- Volunteers
- 121 people
- Sponsor
- Medical University of Silesia
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 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
Peripheral Arterial Disease, Femoropopliteal Lesions
BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably…
- Trial name
- BATTLE (NCT02004951)
- Testing
- Misago RX, Zilver PTX
- Where
- 11 sites in France
- Volunteers
- 186 people
- Sponsor
- Nantes University Hospital
Coronary Artery Disease
The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions
The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de…
- Trial name
- ENDEAVOR IV (NCT00217269)
- Testing
- Coronary Artery Stenting
- Where
- United States
- Volunteers
- 1,548 people
- Sponsor
- Medtronic Vascular
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
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
In-Stent Coronary Artery Restenosis
REWARDS- In-stent Restenosis
To define the long-term incidence and frequency of ISR follow DES implantation. Compare the clinical presentation, treatment and intervention success among de novo coronary artery stenosis and DES ISR.
- Trial name
- NCT03008772
- Where
- United States
- Sponsor
- Medstar Health Research Institute
Coronary Artery Disease, Angina Pectoris
Prevention of Instent Renarrowing With Aggressive Glucose Lowering With Pioglitazone in Diabetic Patients
Patients with diabetes have worse outcomes after percutaneous coronary intervention (PCI) procedures, compared to those patients without diabetes.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Type 2 Diabetes Mellitus, Percutaneous Coronary Intervention
- Trial name
- PPAR-G (NCT00819325)
- Testing
- pioglitazone, oral hypoglycemic agents
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Queen Elizabeth II Health Sciences Centre
Restenosis or Adverse Cardiovascular Event
Endothelial Function and Heart Rate Variability After Stenting
The objective of this study is to evaluate whether impaired endothelial function and low heart rate variability are associated with clinical restenosis after percutaneous coronary intervention with stent implantation in patients…
- Trial name
- FUNKIS (NCT00999323)
- Testing
- stent implantation in coronary artery
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Helse Stavanger HF
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, Coronary Stent Restenosis
A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis
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
- NCT00244647
- Testing
- RESTEN-MP
- Volunteers
- 40 people
- Sponsor
- Sarepta Therapeutics, Inc.
Coronary Artery Stenosis, Coronary Arteriosclerosis
XIENCE V: SPIRIT WOMEN
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female…
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT00496938
- Testing
- XIENCE V®/ XIENCE PRIME™
- Where
- 95 sites in Argentina, Australia and 24 more
- Volunteers
- 1,600 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Diabetes Mellitus
PROVIDENCE:Prevention of Restenosis With Oral Rosiglitazone and the Vision Stent in Diabetics With Coronary Lesions
We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist rosiglitazone will significantly reduce restenosis after…
- Trial name
- NCT00116792
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Gold, Herman K., MD
Coronary Occlusion, Coronary Stenosis
STAR and Deferred Stenting Study
STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a…
- Conditions
- Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
- Trial name
- STAR (NCT05089864)
- Testing
- Stent Placement Timing - Early, Stent Placement Timing - Late
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Saint Luke's Health System
Coronary Artery In-stent Restenosis
Trial for MicroPort's DCB
This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent…
- Trial name
- NCT04386213
- Testing
- coronary artery in-stent restenosis
- Volunteers
- 216 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
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