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French Post-Marketing Surveillance Survey (FR E-REGISTRY)

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ClinicalTrials.gov Identifier: NCT00855478
Recruitment Status : Terminated (Early termination of patient enrollment based on business decision)
First Posted : March 4, 2009
Last Update Posted : November 29, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Cypher stent ™ or Cypher Select ™ Phase 4

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 routines should be applied.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4080 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: French Post-Marketing Surveillance Survey
Study Start Date : May 2006
Primary Completion Date : September 2008
Study Completion Date : September 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Cypher drug-eluting stent
Device: Cypher stent ™ or Cypher Select ™
Cypher drug-eluting stent


Outcome Measures

Primary Outcome Measures :
  1. There is no pre-specified endpoint. [ Time Frame: 12 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
More Information

Responsible Party: Dr. Hans Peter Stoll, MD, Cordis
ClinicalTrials.gov Identifier: NCT00855478     History of Changes
Other Study ID Numbers: 05-FR-002
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: November 29, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases