French Post-Marketing Surveillance Survey - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00855478

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	French Post-Marketing Surveillance Survey

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 11, 2009