TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V patients treated with a 2.25 mm stent. The objective of the study is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels.
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients receiving the TAXUS Liberté-SR 2.25 mm paclitaxel-eluting stent. The results will be compared with two different historical control groups. The first control group consists of a subset of lesion-matched TAXUS V patients treated with a 2.25 mm TAXUS Express-SR paclitaxel-eluting stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the TAXUS Express-SR stent. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels. The second control group consists of a subset of lesion-matched TAXUS V patients treated with either a 2.5 mm or a 2.25 mm bare metal Express stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the Express bare metal stent. The hypothesis is that the TAXUS Liberté-SR stent has superior safety and efficacy to the Express bare metal stent in the treatment of de novo lesions in small coronary vessels.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
261
Paclitaxel-Eluting Coronary Stent, 2.25 mm
Paclitaxel-Eluting Coronary Stent System
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 - 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
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