NCT00232739

Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

A Multicenter, Non-Randomized Study of the 2.25mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native 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-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.

Detailed description

This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. 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 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CYPHER Sirolimus-eluting Coronary Stent	2.25 Cypher Sirolimus-eluting Coronary Stent

Timeline

• Start date: 2003-09-01
• Primary completion: 2004-11-01
• Completion: 2009-08-01
• First posted: 2005-10-05
• Last updated: 2010-03-16
• Results posted: 2010-02-08

Locations

1 site across 1 country: United States