Clinical trials: Coronary Stent Restenosis
Coronary In-stnent Restenosis
Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis
The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge.
- Trial name
- RIBS VII (NCT03167424)
- Testing
- Treatment of restenosis
- Where
- 10 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Spanish Society of Cardiology
Coronary Disease, Coronary Artery Disease
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT II (NCT00180310)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 32 sites in Austria, Belgium and 11 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Coronary Heart Disease
Rapamycin+Estradiol- vs. Rapamycin-Eluting Stents to Reduce Restenosis (ISAR-PEACE)
The purpose of this study is to evaluate whether adding estradiol to rapamycin better prevents coronary artery reblockage after drug-eluting stent implantation.
- Trial name
- NCT00402636
- Testing
- rapamycin plus 17beta estradiolvalerat-eluting stent, rapamycin-eluting stent
- Where
- 2 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Restenosis
Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR I)
The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.
- Trial name
- NCT00106587
- Testing
- PTCA, paclitaxel coated balloon catheter (device with drug)
- Where
- 5 sites in Germany
- Volunteers
- 52 people
- Sponsor
- University Hospital, Saarland
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
Coronary Disease, Coronary Artery Disease
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization.
- Conditions
- Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis
- Trial name
- VICTORY (NCT05346068)
- Testing
- OPN™ NCB Super High Pressure PCI Balloon, Shockwave™ C2 IVL Catheter
- Where
- Switzerland
- Volunteers
- 280 people
- Sponsor
- Luzerner Kantonsspital
Angioplasty, Transluminal, Percutaneous Coronary, Percutaneous Coronary Intervention
To Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study
The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent…
- Trial name
- EREMUS (NCT00870038)
- Testing
- Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent, Percutaneous coronary intervention: Uncoated balloon + Genous stent, Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
- Where
- Italy
- Volunteers
- 75 people
- Sponsor
- Ospedale della Misericordia
In-stent Arterial Restenosis
Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter
The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.
- Trial name
- NCT01495533
- Testing
- uncoated AngioSculpt(R), Drug coated AngioSculpt(R)
- Where
- 3 sites in Brazil, Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital, Saarland
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
ABSORB PHYSIOLOGY Clinical Investigation
The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.
- Trial name
- NCT01308346
- Testing
- Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS), XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 1 people
- Sponsor
- Abbott Medical Devices
Acute Coronary Syndrome
Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome
During the 6-month period 119 patients with acute coronary syndrome, were randomized to either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40).
- Trial name
- NCT00452517
- Testing
- Percutaneous Coronary Intervention
- Where
- Croatia
- Volunteers
- 100 people
- Sponsor
- University of Zagreb
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, Coronary Artery Stenosis
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices
Restenosis, Tight Glycemic Control
Tight Glycemic Control During Angioplasty Revascularization Reduces Coronary Stent Restenosis
A multicentric study will evaluate whether peri-procedural tight glycemic control during angioplasty revascularization for acute coronary syndrome (ACS) reduces circulating inflammatory cytokines and thrombus formation in…
- Trial name
- NCT01016509
- Testing
- Insulin
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- University of Campania Luigi Vanvitelli
Coronary Disease, Coronary Artery Disease
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB UK (NCT01977534)
- Testing
- Absorb BVS
- Where
- 24 sites in United Kingdom
- Volunteers
- 1,005 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis
The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience…
- Trial name
- RESTORE (NCT01967199)
- Testing
- Everolimus-eluting balloon expandable stent, paclitaxel eluting balloon
- Where
- 11 sites in South Korea
- Volunteers
- 175 people
- Sponsor
- Seung-Jung Park
Coronary Artery Disease
A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent
The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode…
- Trial name
- EUCATAX (NCT00825279)
- Testing
- Bare Metal Stent, Drug Eluting Stent
- Where
- 2 sites in Argentina
- Volunteers
- 300 people
- Sponsor
- Centro de estudios en Cardiologia Intervencionista
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
Angioplasty, Chronic Coronary Occlusion
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to: Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort…
- Conditions
- Angioplasty, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease
- Trial name
- XV CHINA SAS (NCT01249027)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,605 people
- Sponsor
- Abbott Medical Devices
Coronary Heart Disease
Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )
In 1970, the first percutaneous balloon coronary angioplasty opened a new chapter of interventional therapy. However, the incidence of intracoronary restenosis was about 30%.
- Trial name
- NCT04119986
- Testing
- drug coated balloon, drug eluted stent
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University