Ischemic Heart Disease Clinical Trial
Official title:
Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease
In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease.
2 Purpose In a randomized study to compare the Cypher Select+ and the Xience V coronary
stents in the treatment of unselected patients with coronary artery disease.
2.1 Primary objective In a randomized study to compare the Xience V and the Cypher Select+
coronary stents by assessing SAFETY (cardiac death, myocardial infarction and/or stent
thrombosis) and EFFICACY (target vessel revascularization) after 9 months.
2.2 Secondary objective To compare device success rate, procedure success rate and
complication rate during hospitalization, after 1 month and after 9 months and the incidence
of late stent thrombosis after 12, 24 and 36 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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