NCT00381420

The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.

A Canadian 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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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® Stent Delivery Systems. The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year, 3 and 5 years).

Detailed description

This is a multicenter ,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 Raptor® Stent Delivery Systems. A total of 100 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to Treatment A or Treatment B. Neither the investigator nor the patient will know which stent will be implanted. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 8 months. Additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 5 years follow-up period will be collected and analyzed.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	drug-eluting stent	sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
DEVICE	bare-metal stent	un-coated Bx VELOCITY Stent

Timeline

• Start date: 2001-03-01
• Primary completion: 2002-12-01
• Completion: 2008-06-01
• First posted: 2006-09-27
• Last updated: 2008-10-31