Status:

TERMINATED

French Post-Marketing Surveillance Survey

Lead Sponsor:

Cordis US Corp.

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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

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 r...

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

May 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2008

Estimated Enrollment :

4080 Patients enrolled

Trial Details

Trial ID

NCT00855478

Start Date

May 1 2006

End Date

September 1 2008

Last Update

November 29 2010

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