NCT00371748

A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V patients treated with a 2.25 mm stent. The objective of the study is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels.

Detailed description

TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients receiving the TAXUS Liberté-SR 2.25 mm paclitaxel-eluting stent. The results will be compared with two different historical control groups. The first control group consists of a subset of lesion-matched TAXUS V patients treated with a 2.25 mm TAXUS Express-SR paclitaxel-eluting stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the TAXUS Express-SR stent. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels. The second control group consists of a subset of lesion-matched TAXUS V patients treated with either a 2.5 mm or a 2.25 mm bare metal Express stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the Express bare metal stent. The hypothesis is that the TAXUS Liberté-SR stent has superior safety and efficacy to the Express bare metal stent in the treatment of de novo lesions in small coronary vessels.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	TAXUS Liberté-SR	Paclitaxel-Eluting Coronary Stent, 2.25 mm
DEVICE	TAXUS™ Express2	Paclitaxel-Eluting Coronary Stent System
DEVICE	Express2	Coronary Stent System

Timeline

• Start date: 2005-02-01
• Primary completion: 2006-12-01
• Completion: 2011-04-01
• First posted: 2006-09-04
• Last updated: 2012-02-02

Locations

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