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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
871
Paclitaxel-Eluting Coronary Stent System
Paclitaxel-Eluting Coronary Stent System
Baptist Medical Center Princeton Cardiology PC
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Brotman Medical Center
Beverly Hills, California, United States
Mercy General Hospital
Sacramento, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
9-Month Target Vessel Revascularization (TVR)
Time frame: 9 Months
Clinical procedural and technical success
Time frame: 5 Years
Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)
Time frame: 9 Months
MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.
Time frame: 5 Years
Stent thrombosis rate
Time frame: 5 Years
Target Vessel Failure (TVF)
Time frame: 5 Years
QCA parameters (binary restenosis rate, MLD and late loss)
Time frame: 9 Months
IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset
Time frame: 9 Months
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University of California San Diego Medical Center
San Diego, California, United States
St. Joseph's Medical Center
Stockton, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Christiana Hospital
Newark, Delaware, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
...and 52 more locations