The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).
This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers). A total of 110 patients with at least two de novo native coronary artery lesions (lesion A, lesion B) ≤ 30 mm in length and ≥ 2.25 mm to \< 3.0 mm in diameter by visual estimate will be enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A and B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
112
TAXUS(TM) Paclitaxel-eluting stent
Sirolimus eluting Cypher Select(TM) stent
Albert-Ludwig University Clinic
Freiburg im Breisgau, Baden-Wurttemberg, Germany
The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography
Time frame: 8 months
Target lesion and vessel revascularization (TLR, TVR)
Time frame: 12 months
Major adverse cardiac events (MACE) at 30 days, 8 and 12 months
Time frame: 30 days, 8 and 12 months
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