The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions. — E-SIRIUS  

Coronary Artery Disease Clinical Trial

Official title: E-Sirius Study: a European, Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions

Status Completed

Clinical Trial Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.

Clinical Trial Description

This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT00235144
• Study type: Interventional
• Source: Cordis Corporation
• Status: Completed
• Phase: Phase 3
• Start date: March 2001
• Completion date: September 2008