Coronary Artery Disease Clinical Trial
Official title:
A Prospective Registry for the Use of CypherTM Sirolimus-Eluting Stents In Patients With Coronary Artery Disease Treated With Percutaneous Coronary Interventions at Scripps Clinic
This study is a prospective, non-randomized, open-label registry of consecutive patients
with CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts
will be included in the registry. The registry is conducted for the evaluation of the impact
of CypherTM Sirolimus-eluting stent implantation in the "real world" of interventional
cardiology. Informed consent will be obtained from patients meeting the inclusion criteria
before the initiation of any study specific procedures. Consecutive patients treated with
the use of the CypherTM stent will be included in the registry. Baseline and post-procedure
blood samples will be used to perform platelet function analysis using the Accumetrics
Ultegra RPFA (Rapid Platelet Function Assay).
All patients will be followed from enrollment through the hospital discharge for any
clinically significant event (death, myocardial infarction, TLR, TVR, major or minor
bleeding). A follow-up telephone assessment of death, myocardial infarction,
revascularization, and medical treatment will be conducted by experienced research personnel
at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial
infarctions and revascularizations will be adjudicated by an independent Clinical Events
Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750
patients will be conducted and data forwarded to FDA.
n/a
Time Perspective: Prospective
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