NCT00371423

Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Direct Stenting Treatment of Patients With de Novo Coronary Artery Lesions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	TAXUS Liberté™-SR	Paclitaxel-Eluting Coronary Stent System
DEVICE	TAXUS Liberté™-SR	Paclitaxel-Eluting Coronary Stent System

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-06-01
• Completion: 2010-09-01
• First posted: 2006-09-04
• Last updated: 2012-02-02

Locations

25 sites across 4 countries: United States, New Zealand, Singapore, Taiwan