French Post-Marketing Surveillance Survey

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00855478

Acronym

FR E-REGISTRY

Enrollment

4080

Registered

2009-03-04

Start date

2006-05-31

Completion date

2008-09-30

Last updated

2010-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICECypher stent ™ or Cypher Select ™

Cypher drug-eluting stent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame
There is no pre-specified endpoint.	12 Months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026