NCT00232830

The Study to Assess AMI Treated With Balloon Angioplasty.

Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 715 (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 effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.

Detailed description

This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents. Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	drug-eluting stent	Cypher Sirolimus-eluting Coronary Stent
DEVICE	bare-metal stent	any bare-metal stent brand

Timeline

• Start date: 2003-10-01
• Primary completion: 2009-02-01
• Completion: 2009-04-01
• First posted: 2005-10-05
• Last updated: 2009-09-16

Locations

2 sites across 2 countries: France, Germany