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

NCT00371423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2012-02-02

No results posted yet for this study

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

Interventions

DEVICE

TAXUS Liberté™-SR

Paclitaxel-Eluting Coronary Stent System

DEVICE

TAXUS Liberté™-SR

Paclitaxel-Eluting Coronary Stent System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • John A Ormiston, MD · Mercy Hospital

  • Mark A Turco, MD · Washington Adventist 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
2005-03-31
Primary Completion
2006-06-30
Completion
2010-09-30

Countries

  • United States
  • 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 NCT00371423 on ClinicalTrials.gov