NCT00232791

The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.

A Randomized Study With the CYPHER SELECT™ Sirolimus-Eluting Balloon-Expandable Coronary Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.

Detailed description

This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions \<23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Cypher Select	CYPHER SELECT™ Sirolimus-eluting Coronary Stent
DEVICE	Cypher	CYPHER™ Sirolimus-eluting Coronary Stent

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-08-01
• Completion: 2005-03-01
• First posted: 2005-10-05
• Last updated: 2008-08-06

Locations

1 site across 1 country: United Kingdom