Clinical trials: In-stent Restenosis
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
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
Graft Occlusion, Vascular, Coronary Restenosis
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive…
- Conditions
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- Trial name
- NCT00055510
- Testing
- BO-653
- Where
- 29 sites in United States
- Sponsor
- Chugai Pharma USA
In-stent Restenosis
CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.
- Trial name
- NCT05731700
- Testing
- Drug Eluting Balloon
- Where
- 9 sites in France, Georgia and 2 more
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
In-stent Restenosis Lesion
Comparison of the Efficacy of Paclitaxel-releasing Balloon Catheter System Versus the Everolimus-Eluting Stent System for Treatment of In-Stent Restenosis Lesions - Harmonizing Optimal Strategy for Treatment of In-Stent Restenosis Lesions (The HOST-ISR Trial) -
In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era.
- Trial name
- NCT01093300
- Testing
- Paclitaxel-eluting balloon catheter, Everolimus-eluting stent
- Where
- South Korea
- Volunteers
- 264 people
- Sponsor
- Seoul National University Hospital
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 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.
Stent Restenosis, Coronary Artery Disease
Effect of Exercise Training in Coronary Artery Disease Patients After Stenting
To determine the effects of exercise training on ankle-brachial index and Quality of Life in coronary artery disease patients after stenting.
- Trial name
- NCT05315193
- Testing
- Structured In-patient and Home plan, Conventional Therapy
- Where
- Pakistan
- Volunteers
- 73 people
- Sponsor
- Riphah International University
PERIPHERAL VASCULAR DISEASE
Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease
Despite recent advances in stent technology and its widespread application in the treatment of peripheral vascular disease (PVD), incidences of partial or complete blockage of stent lumen (in-stent restenosis) due to in growth of…
- Trial name
- COBRA (NCT00827853)
- Testing
- Conventional angioplasty balloon, cryoplasty balloon
- Where
- 4 sites in United States
- Volunteers
- 90 people
- Sponsor
- North Texas Veterans Healthcare System
Metal Allergy, Contact Allergy
Metal Allergy In-Stent Restenosis Study
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation.
- Conditions
- Metal Allergy, Contact Allergy, Restenoses, Coronary, In-stent Restenosis
- Trial name
- RESTALL (NCT03588962)
- Testing
- In-stent restenosis
- Volunteers
- 1,000 people
- Sponsor
- Silesian Centre for Heart Diseases
Atherosclerosis, Restenosis
Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis
clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated with a coronary bare metal stent. Recent research has identified endothelial progenitor cells as well as dendritic cells as components…
- Trial name
- NCT00493597
- Where
- Belgium
- Volunteers
- 124 people
- Sponsor
- University Hospital, Antwerp
Angioplasty, Balloon
Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis
The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in…
- Trial name
- INTACT (NCT02599389)
- Testing
- Drug-coated balloons, Excimer Laser
- Where
- 13 sites in France
- Volunteers
- 222 people
- Sponsor
- University Hospital, Bordeaux
In-stent Restenosis
Diffuse Type In-Stent Restenosis After Drug-Eluting Stent
To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.
- Trial name
- DES-ISR (NCT00485030)
- Testing
- Cypher, Xience-V
- Where
- 15 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Seung-Jung Park
Mesenteric Ischemia, Bowel; Ischemic
Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia
Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition.
- Conditions
- Mesenteric Ischemia, Bowel; Ischemic, Superior Mesenteric Atherosclerosis, Mesenteric Artery Stenosis
- Trial name
- COMESS (NCT05244629)
- Testing
- BMS vs. CS
- Where
- Denmark
- Volunteers
- 98 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
CHD - Coronary Heart Disease, Percutaneous Coronary Intervention
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
- Conditions
- CHD - Coronary Heart Disease, Percutaneous Coronary Intervention, In-stent Restenosis
- Trial name
- NCT03809754
- Testing
- Percutaneous Coronary Intervention under OCT, Percutaneous Coronary Intervention under Angiography
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Chinese PLA General 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 Artery Disease, Coronary Restenosis
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant…
- Trial name
- NCT00426049
- Testing
- Everolimus
- Where
- Germany
- Volunteers
- 484 people
- Sponsor
- German Heart Institute
Patients Above 18 Years
Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee
The Below-Study is a randomized, prospective mono-centre trial on the efficacy and safety the adjunctive use of a GP IIb/IIIa antagonist for prevention of early reocclusion in arterial below-the knee interventions.
- Trial name
- NCT00163254
- Testing
- abciximab, stent and drug eluting stent
- Where
- Germany
- Sponsor
- University Hospital Tuebingen
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
Coronary Artery Disease, Type 2 Diabetes Mellitus
Comparison Between Pioglitazone and SES With type2 DM
Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents.
- Trial name
- NCT00482183
- Testing
- Pioglitazone
- Volunteers
- 38 people
- Sponsor
- Showa University