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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
247
Paclitaxel-Eluting Coronary Stent System
Paclitaxel-Eluting Coronary Stent System
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
...and 15 more locations
Analysis segment percent diameter stenosis at 9-months
Time frame: 9 Months
Secondary Endpoints: Clinical procedural and technical success
Time frame: 5 years
Utilization parameters (equipment utilization, 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 and area volumes, neointimal area volume)
Time frame: 9 Months
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