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French Post-Marketing Surveillance Survey

NCT ID: NCT00855478

Last Updated: 2010-11-29

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-09-30

Brief Summary

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To assess the safety and effecacy of the Cypher stent ™ \& Cypher Select ™ in the normal use of medical practices, within the labeled indications.

Detailed Description

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Multi-center, retrospective and prospective French register. This register does not impose any constraint on the evaluated population, the procedure, or the required examinations. The local practice routines should be applied.

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 drug-eluting stent

Group Type EXPERIMENTAL

Cypher stent ™ or Cypher Select ™

Intervention Type DEVICE

Cypher drug-eluting stent

Interventions

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Cypher stent ™ or Cypher Select ™

Cypher drug-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic ischemic heart disease due to de novo lesions (lesions \<30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries.

Exclusion Criteria

* Patients suffering from coronary heart disease.
* Patients for whom treatment antiplatelet and / or anticoagulant is against the state;
* Patients with injuries incompatible with the full inflation of a balloon angioplasty;
* Transplant patients ;
* Patients with known allergy to Sirolimus, the stainless steel 316L, to polymethacrylates or copolymers polyolefins;
Minimum Eligible Age

18 Years

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

Other Identifiers

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05-FR-002

Identifier Type: -

Identifier Source: org_study_id