Coronary Artery Disease Clinical Trial
Official title:
Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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