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

This study has been terminated.
(Early termination of patient enrollment based on business decision)
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00855478
First received: March 3, 2009
Last updated: November 25, 2010
Last verified: November 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: French Post-Marketing Surveillance Survey

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • There is no pre-specified endpoint. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Enrollment: 4080
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cypher drug-eluting stent
 Device: Cypher stent ™ or Cypher Select ™
Cypher drug-eluting stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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;
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Hans Peter Stoll, MD, Cordis
ClinicalTrials.gov Identifier: NCT00855478     History of Changes
Other Study ID Numbers: 05-FR-002
Study First Received: March 3, 2009
Last Updated: November 25, 2010
Health Authority: France: Commission Nationale de l'Informatique et des Libertés
France: Ministére Déléqué à la Recherche

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

ClinicalTrials.gov processed this record on May 16, 2013