NCT04315168CompletedNot Applicable
Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment
Microvention-Terumo, Inc.1 site in 1 country135 target enrollmentStarted: June 12, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Mortality Rate
Study Overview
Brief Summary
A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms
Detailed Description
Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.
Sample Size: 138 patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR
- •Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mortality Rate
Time Frame: 1 year
Percentage of patients with neurological death
Morbidity Rate
Time Frame: 1 year
Percentage of patients with major ipsilateral stroke
Secondary Outcomes
- modified Rankin Score(1 year)
- Complete aneurysm occlusion rate(1 year)
- Retreatment Rate(1 year)
- Patient description(1 year)
Investigators
Study Sites (1)
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