NCT00232765

Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)

A Multicenter, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,058 (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 VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.

Detailed description

This is a multicenter (55 sites), prospective, 2-arm randomized, double-blind study designed to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent as compared to the uncoated Bx VELOCITYTM stent. A total of 1100 patients will be entered in the study and will be randomized on a 1:1 basis. Patients with de novo native coronary artery lesions \>/=15mm and \</=30mm in length and \>/=2.50mm to \</=3.5mm in diameter by visual estimate who meet all eligibility criteria will be either randomized to the sirolimus-coated Bx VELOCITYTM stent or the uncoated Bx VELOCITYTM stent. Patients will be followed at 30 days, 3, 6, 9 and 12 months, and 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with approximately 850 patients having repeat angiography at 8 months. A subset of approximately 17 centers will participate in an intravascular ultrasound (IVUS) sub study, in which all patients at these centers will be enrolled in the sub study. Additionally, data will be collected for a medical economic analysis. These data will include costs associated with the index hospitalization and length of stay, and rehospitalizations during the 12-month follow-up period. This is a single lesion treatment study. Patients who have had interventions of other lesions within 30 days of the study procedure or have interventions planned after the index procedure are excluded. It is anticipated that the total length of the study will be 101 months: 5 months to complete patient enrollment and 8 years for follow-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CYPHER Sirolimus-Eluting Stent	CYPHER Sirolimus-Eluting Stent
DEVICE	Uncoated BX VELOCITY Balloon-Expandable Stent	Uncoated BX VELOCITY Balloon-Expandable Stent

Timeline

• Start date: 2001-02-01
• Primary completion: 2002-05-01
• Completion: 2008-11-01
• First posted: 2005-10-05
• Last updated: 2009-09-16

Locations

1 site across 1 country: United States