The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.
Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,701
Drug eluting stent
Drug eluting stent
Duke University Medical Center
Durham, North Carolina, United States
Christ Linder
Cincinnati, Ohio, United States
MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
Time frame: 8 months
In-segment late lumen loss
Time frame: 9 months
Device, lesion and procedure success
Time frame: At procedure or hospital discharge
Incidence of MACE
Time frame: 30 days, 9 months and 12 months
Coronary angiography in the angiographic cohort
Time frame: 9 months
Target lesion revascularization
Time frame: 8 months
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