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

NCT00371709 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 871

Last updated 2012-02-02

No results posted yet for this study

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

Interventions

DEVICE

TAXUS Liberté-SR

Paclitaxel-Eluting Coronary Stent System

DEVICE

TAXUS™ Express

Paclitaxel-Eluting Coronary Stent System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Mark A Turco, MD · Washington Adventist Hospital

  • John A Ormiston, MD · Mercy Hospital

  • Peter Maurer, MPH · Boston Scientific Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-11-30
Completion
2010-03-31

Countries

  • United States
  • Australia
  • Canada
  • China
  • New Zealand
  • Singapore
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00371709 on ClinicalTrials.gov