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A Multi-center Post-Market Surveillance Registry

NCT ID: NCT00438919

Last Updated: 2009-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Group Type EXPERIMENTAL

drug-eluting stent

Intervention Type DEVICE

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Interventions

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drug-eluting stent

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Cordis

Principal Investigators

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Philip Urban, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique La Tour

Locations

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Clinique La Tour

Meyrin, , Switzerland

Site Status

Countries

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Switzerland

References

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Urban P, Abizaid A, Banning A, Bartorelli AL, Baux AC, Dzavik V, Ellis S, Gao R, Holmes D, Jeong MH, Legrand V, Neumann FJ, Nyakern M, Spaulding C, Worthley S; e-SELECT Investigators. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry. J Am Coll Cardiol. 2011 Mar 29;57(13):1445-54. doi: 10.1016/j.jacc.2010.11.028.

Reference Type DERIVED
PMID: 21435513 (View on PubMed)

Other Identifiers

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EC06-01

Identifier Type: -

Identifier Source: org_study_id