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A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions — SCORPIUS  

Coronary Artery Disease Clinical Trial

Official title:
A German Multicenter, Randomized, Controlled, Open-Label Study of the Cypher Sirolimus-Eluting Stent in the Treatment of Diabetic Patients With De Novo Native Coronary Artery Lesions

Clinical Trial Summary

The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.

Clinical Trial Description

This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions <= 42 mm in length and >=2.5mm and <=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month).

It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00495898
Study type Interventional
Source Cordis Corporation
Contact
Status Completed
Phase Phase 4
Start date November 2002
Completion date November 2009
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