Clinical Trials Logo
  1. Home
  2. Coronary Restenosis
  3. NCT03667313

Treatment of In-Stent Restenosis 2 Study — TIS2  

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

Clinical Trial Summary

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).

Clinical Trial Description

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]). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03667313
Study type Interventional
Source University Hospital Ostrava
Contact
Status Completed
Phase Phase 3
Start date October 1, 2018
Completion date December 31, 2021
View Details
See also
  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 NCT01205789 - EXCEL Clinical Trial (Universal Registry) N/A
Completed NCT01274234 - OCT Evaluation of Healing of COMBO Stent Phase 1/Phase 2
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