NCT00371709

TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 871 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control. The control group is a case-matched, blended population of TAXUS Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate clinical outcomes of TAXUS Liberté-SR stent in de novo lesions and to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.

Conditions

• Coronary Artery Disease

Interventions

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

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-11-01
• Completion: 2010-03-01
• First posted: 2006-09-04
• Last updated: 2012-02-02

Locations

62 sites across 7 countries: United States, Australia, Canada, China, New Zealand, Singapore, Taiwan