To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,200
Zotarolimus coated coronary stent (10ug/mm)
Dr. J. Fajedet
Clinique Pasteur, France
Target Vessel Failure Rate at 9 months post procedure
Time frame: 9 months
Device Success Lesion Success Procedure Success Major Cardiac Adverse Events (MACE) at 30 days and 6, 9, and 12 months, and annually thereafter out to 5 years. Late loss at 8 months as measured by QCA
Time frame: 30 days and 6, 9, and 12 months, and annually thereafter out to 5 years.
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