A Multi-center Post-Market Surveillance Registry

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: drug-eluting stent

• Registration Number: NCT00438919
• Lead Sponsor: Cordis Corporation

Brief Summary

This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.

Detailed Description

The data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure. While no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the stenting procedure, application of antiplatelet medication and any other medical therapy should be provided according to local usual practice. Data collection (Electronic Data Capture), data management, statistical analyses, monitoring and core laboratory evaluations will be assigned to independent organizations.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-21
• Study First Posted: 2007-02-22
• Status Verified: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-02
• Last Update Posted: 2009-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure;
• Males and females;

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	drug-eluting stent	CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Primary Outcome Measures

Name	Time	Method
acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)	1, 6, 12, 24 and 36 months

Trial Locations

Locations (1)

Clinique La Tour; 🇨🇭 Meyrin, Switzerland