Coronary Artery Disease Clinical Trial
Official title:
A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Prospective, randomized, active-control, single blind, parallel two-arm multi-center
clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved
commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
System.
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston
Scientific.
The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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