The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.
This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents. Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
715
Cypher Sirolimus-eluting Coronary Stent
any bare-metal stent brand
HOPITAL COCHIN, René Descartes University
Paris, France
University of Freiburg, Albert-Ludwigs-Universitätskliniken
Freiburg im Breisgau, Germany
Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.
Time frame: 1 and 6 months and at 1, 3, 4, and 5 years post-procedure.
cardiac death
Time frame: 1, 3, 4 and 5 years post-procedure
recurrence of myocardial infarction
Time frame: 1, 3, 4 and 5 years post-procedure
revascularization of the target vessel (TVR)
Time frame: 1, 3, 4 and 5 years post-procedure
recurrence of ischemia
Time frame: 1, 3, 4 and 5 years post-procedure
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