Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

In-stent Arterial Restenosis Clinical Trial

Official title: Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study

Status Completed

Clinical Trial Summary

The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Clinical Trial Description

Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization. ;

Related Conditions & MeSH terms

• In-stent Arterial Restenosis

• NCT number: NCT01495533
• Study type: Interventional
• Source: Universität des Saarlandes
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Completion date: July 2014