NCT00233714

Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions

A Randomized Feasibility Study of the Double Dose or Single Dose Sirolimus-Eluting BX VELOCITY Balloon-Expandable Stent for the Treatment of Diabetic Patients With de Novo Native Coronary Artery Lesions(3D)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (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 safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CYPHER Sirolimus-Eluting Coronary Stent	Single dose Sirolimus-Eluting coronary stent
DEVICE	CYPHER Sirolimus-Eluting Coronary Stent	Double-dose Sirolimus-Eluting coronary stent

Timeline

• Start date: 2003-05-01
• Primary completion: 2004-07-01
• Completion: 2009-11-01
• First posted: 2005-10-06
• Last updated: 2009-11-19

Locations

1 site across 1 country: Brazil