The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.5-3.5 mm.
The ENDEAVOR IV Trial is a prospective, multi-center, randomized, two-arm, single-blind trial that will enroll a total of 1,548 patients at up to 80 sites in the US. The ENDEAVOR IV Trial will assess if the Endeavor stent is equivalent in safety and efficacy to the Taxus stent for the treatment of single de novo lesions in native coronary arteries with a RVD of 2.5-3.5 mm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,548
Endeavor Drug eluting stent
Taxus Drug Eluting Stent
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States
Target vessel failure (TVF) rate
Time frame: 9 months
Angiographic parameters (in-stent and in-segment) including: percent diameter stenosis (%DS)
Time frame: 8 months
Late lumen loss (in-segment late lumen loss is a powered secondary endpoint)
Time frame: 9 months
Late loss index
Time frame: 9 months
Angiographic binary restenosis (ABR) rate
Time frame: 9 months
Minimum luminal diameter (MLD)
Time frame: 9 months
Major adverse cardiac event (MACE) rate
Time frame: 30 days, 6, 9, and 12 months
Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)
Time frame: 8 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.