NCT01495533

Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• In-stent Arterial Restenosis

Interventions

Type	Name	Description
DEVICE	uncoated AngioSculpt(R)	Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)
COMBINATION_PRODUCT	Drug coated AngioSculpt(R)	Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-12-01
• Completion: 2014-07-01
• First posted: 2011-12-20
• Last updated: 2023-04-27

Locations

3 sites across 2 countries: Brazil, Germany