Back to resultsFrench Post-Marketing Surveillance Survey (FR E-REGISTRY)
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cypher stent ™ or Cypher Select ™
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Cypher drug-eluting stent
Outcomes
Primary Outcome Measures
There is no pre-specified endpoint.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00855478
Brief Title
French Post-Marketing Surveillance Survey
Acronym
FR E-REGISTRY
Official Title
French Post-Marketing Surveillance Survey
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Early termination of patient enrollment based on business decision
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4080 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cypher drug-eluting stent
Intervention Type
Device
Intervention Name(s)
Cypher stent ™ or Cypher Select ™
Intervention Description
Cypher drug-eluting stent
Primary Outcome Measure Information:
Title
There is no pre-specified endpoint.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
12. IPD Sharing Statement
Learn more about this trial
French Post-Marketing Surveillance Survey
We'll reach out to this number within 24 hrs