Clinical Trials Directory

Trials / Completed

CompletedNCT00371475

A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
150 (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 38 mm stent to an historical TAXUS Express control. The control group is a case-matched, blended, long lesion subset 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 38 mm 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

Interventions

TypeNameDescription
DEVICETAXUS Liberté-SRPaclitaxel-Eluting Coronary 38 mm Stent
DEVICETAXUS™ ExpressPaclitaxel-Eluting Coronary Stent System

Timeline

Start date
2005-03-01
Primary completion
2007-02-01
Completion
2011-05-01
First posted
2006-09-04
Last updated
2012-02-02

Locations

25 sites across 3 countries: United States, New Zealand, Singapore

Source: ClinicalTrials.gov record NCT00371475. Inclusion in this directory is not an endorsement.