A Multi-center Post-Market Surveillance Registry

Coronary Artery Disease Clinical Trial

— E-SELECT  

Official title:

The e-SELECT Registry a MULTICENTER POST-MARKET SURVEILLANCE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438919
• Other study ID #: EC06-01
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2007
• Last updated: December 2, 2009
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: competent authorities
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug-eluting stent
CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Locations

Country	Name	City	State
Switzerland	Clinique La Tour	Meyrin

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)		1, 6, 12, 24 and 36 months	Yes