Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA) — ISRII  

In-Stent Restenosis Clinical Trial

Official title: Efficacy Evaluation of In-bare Metal Stent Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter. Study With Intravascular Ultrasound and Optical Coherence Tomography

Status Recruiting

Clinical Trial Summary

The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.

Clinical Trial Description

Study aims:

• Clinical efficacy evaluation of different treatment's strategies, including periprocedural and long-term endpoints defined as: death, myocardial infarction, brain stroke, necessity of repeated revascularization

• Evaluation of intravascular ultrasound (IVUS) as an optimisation method for direct and long-term revascularization effects

• Evaluation of optical coherence tomography as an optimisation method for direct and long-term revascularization effects

• Evaluation of late lumen loss and neointimal hyperplasia in stent in long-term follow-up

• Analysis of direct and indirect medical costs of alternative treatment strategies

Study group:

200 patients with symptomatic restenosis evidenced angiographically in bare metal stent implanted in native coronary artery. Patients will be randomised to 2 therapeutic groups:

• Patients treated with rapamycin eluting stent (n=100)

• Patients treated with paclitaxel eluting balloon catheter (n=100) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-Stent Restenosis

• NCT number: NCT01255956
• Study type: Interventional
• Source: Medical University of Warsaw
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2010
• Completion date: July 2012