French Post-Marketing Surveillance Survey

Coronary Artery Disease Clinical Trial

— FR E-REGISTRY  

Official title:

French Post-Marketing Surveillance Survey

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00855478
• Other study ID #: 05-FR-002
• Status: Terminated
• Phase: Phase 4
• First received: March 3, 2009
• Last updated: November 25, 2010
• Start date: May 2006
• Est. completion date: September 2008

Study information

• Verified date: November 2010
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 4080
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Cypher stent ™ or Cypher Select ™
Cypher drug-eluting stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	There is no pre-specified endpoint.		12 Months