NCT01255956

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

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• In-Stent Restenosis

Interventions

Type	Name	Description
DEVICE	Rapamycin eluting stent implantation	Rapamycin eluting stent implantation for in-stent restenosis treatment
DEVICE	Paclitaxel eluting balloon catheter	Paclitaxel eluting balloon catheter for in-stent restenosis treatment

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-12-08
• Last updated: 2011-01-25

Locations

4 sites across 1 country: Poland