French Post-Marketing Surveillance Survey
Phase 4
Terminated
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00855478
- Lead Sponsor
- Cordis Corporation
- 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 routines should be applied.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4080
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method There is no pre-specified endpoint. 12 Months
- Secondary Outcome Measures
Name Time Method