To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter.
The ENDEAVOR III Trial is a prospective, multi-center, single-blind, randomized trial that enrolled 436 patients at 29 sites in the US. The purpose of this trial is to demonstrate the equivalency of in-segment late lumen loss at 8 months between the Endeavor stent and the Cypher stent for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter. Patients were randomized to receive the Endeavor stent or the Cypher Sirolimus-Eluting Coronary Stent System. Enrollment was completed in September 2004.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
436
Endeavor Drug Eluting Stent
Cypher Drug Eluting Stent
In-segment late lumen loss
Time frame: 8 months
Device Success
Time frame: 9 months
Lesion Success
Time frame: 9 months
Procedure Success
Time frame: 9 months
Major Adverse Cardiac Event (MACE) rate
Time frame: 30 days, 6, 9, and 12 months
Target Site Revascularization (TSR) rate and clinically-driven TSR rate
Time frame: 9 months
Target Vessel Revascularization (TVR) rate and clinically-driven TVR rate
Time frame: 9 months
Target Vessel Failure (TVF) rate
Time frame: 9 months
Angiographic binary restenosis (> 50% diameter stenosis) rate
Time frame: 8 months
In-stent and in-segment minimum lumen diameter (MLD)
Time frame: 8 months
Neointimal hyperplastic volume as measured by IVUS
Time frame: 8 months
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