Coronary Artery Disease Clinical Trial
Official title:
A Randomized Comparison of the Supralimus® Stent With the Xience V™ Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.
Series III Run-In is a prospective, multi-center, randomized, single-blind (patient-blind),
non-inferiority trial to be conducted at approx. 35 interventional cardiology centers in
India, Brazil, Argentina, Thailand and Saudi Aurabia. A total of 360 will be randomized on a
2:1 basis to either the Supralimus® (sirolimus-eluting) stent or the Xience V™
(everolimus-eluting) stent.
In selected sites, IVUS will also be recorded in these patients (maximum of 60 IVUS patients
in total), at baseline (post-procedure) and at 9-month follow-up.
All patients will be followed clinically for up to 5 years after stent implantation. Repeat
angiography will be performed in all patients at 9 months after the index procedure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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