Coronary Restenosis Clinical Trial
Official title:
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).
Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents (DES) or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB (paclitaxel-eluting balloon catheters; PEB). In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface, due to insufficient tissue uptake and shorter tissue retention of limus drugs. It was found that phospholipid-encapsulated sirolimus nanoparticles could be used for coating balloon catheters to provide efficient drug transfer to vessel wall with high tissue concentration. This prospective randomized non-inferiority study compares the efficacy of new sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR). The primary end-point is in-segment late lumen loss (LLL) at 12 months as measured by quantitative coronary angiography (QCA). Secondary end-points are the incidence of binary ISR (˃50% DS) and the overall incidence of 12-month major adverse cardiac events (MACE; cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
Completed |
NCT02263313 -
EGO-COMBO Clinical End-point Extension Study Beyond 36 Months
|
N/A | |
Completed |
NCT00248066 -
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
|
Phase 2 | |
Completed |
NCT00148356 -
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT02508714 -
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
|
N/A | |
Completed |
NCT01274234 -
OCT Evaluation of Healing of COMBO Stent
|
Phase 1/Phase 2 | |
Completed |
NCT01205789 -
EXCEL Clinical Trial (Universal Registry)
|
N/A | |
Recruiting |
NCT00426049 -
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
|
Phase 3 | |
Terminated |
NCT00243308 -
Serp-1 for the Treatment of Acute Coronary Syndrome
|
Phase 2 | |
Completed |
NCT00180466 -
PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions
|
N/A | |
Completed |
NCT00859183 -
Oral Sirolimus for In-Stent Restenosis
|
Phase 4 | |
Recruiting |
NCT05089864 -
STAR and Deferred Stenting Study
|
N/A | |
Active, not recruiting |
NCT02175706 -
DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity
|
N/A | |
Completed |
NCT01249027 -
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
|
||
Completed |
NCT01331707 -
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
|
Phase 4 | |
Recruiting |
NCT00500279 -
Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
|
Phase 4 | |
Completed |
NCT00402272 -
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
|
Phase 4 | |
Completed |
NCT01171820 -
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)
|
Phase 4 | |
Recruiting |
NCT06075602 -
COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease
|