CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Phase 4

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00245401
• Lead Sponsor: Cordis Corporation

Brief Summary

The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing approval, when used in normal clinical practice within the labeled indications.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study Completion: 2004-12
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-28
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-03
• Last Update Posted: 2007-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2070

Inclusion Criteria

• Cypher stent

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MACE at 30 days, 6 months and 1 year.

Secondary Outcome Measures

Name	Time	Method
There is no pre-specified secondary outcome.