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

Cordis

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Cypher stent ™ or Cypher Select ™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855478

05-FR-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,080 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4,080 participants in 1 patient group

1

Experimental group

Description:

Cypher drug-eluting stent

Treatment:

Device: Cypher stent ™ or Cypher Select ™