TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté 38 mm stent to an historical TAXUS Express control. The control group is a case-matched, blended, long lesion subset 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 38 mm 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
150
Paclitaxel-Eluting Coronary 38 mm Stent
Paclitaxel-Eluting Coronary Stent System
Mercy General Hospital
Sacramento, California, United States
Christiana Hospital
Newark, Delaware, United States
Florida Hospital
Orlando, Florida, 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
Northern Michigan Hospital
Petoskey, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
...and 15 more locations
Percent diameter stenosis of the analysis segment at 9-months
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
Target Vessel Revascularization (TVR)
Time frame: 5 Years
QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)
Time frame: 9 Months
IVUS parameters (percent net volume obstruction, incomplete apposition, stent areas and volume, vessel areas and volume, lumen areas and volume, neointimal area volume)
Time frame: 9 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.