NCT00232856

A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.

A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (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 Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.

Detailed description

This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	drug-eluting stent	PCI

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-12-01
• Completion: 2006-08-01
• First posted: 2005-10-05
• Last updated: 2008-04-30

Locations

2 sites across 2 countries: Belgium, Germany