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

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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

Key facts

Study ID

NCT00371423

Run by

Boston Scientific Corporation

People needed

247

Starts

2005-03-01

Expected to finish

2010-09-01

Last updated by the study team

2012-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems — Little Rock, Arkansas, United States
• Mercy General Hospital — Sacramento, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Florida Hospital — Orlando, Florida, United States
• St. Anthony's Medical Center — Rockford, Illinois, United States
• St. John's Hospital — Springfield, Illinois, United States
• The Heart Center — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• Northern Michigan Hospital — Petoskey, Michigan, United States
• St. Mary's Duluth Clinic Regional Heart Center — Duluth, Minnesota, United States
• Wake Medical Center — Raleigh, North Carolina, United States
• Oklahoma Foundation for Cardiovascular Research — Oklahoma City, Oklahoma, United States
• The Pennsylvania State University Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States
• Northwest Cardiovascular Research Institute — Spokane, Washington, United States
• Mercy Angiography Unit, 98 Mountain Road, First Floor — Auckland, Epsom, New Zealand
• Auckland City Hospital — Auckland, New Zealand
• Christchurch Hospital — Christchurch, New Zealand
• Dunedin Hospital — Dunedin, New Zealand
• National University Hospital — Singapore, Singapore
• National Heart Centre — Singapore, Singapore
• Shin Kong Memorial Hospital — Shih Lin Taipei, Taiwan

Full record on ClinicalTrials.gov

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