Status:
COMPLETED
FRED and FRED JR Devices for Intracranial Aneurysm Treatment
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
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.
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
June 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04315168
Start Date
June 12 2020
End Date
December 31 2023
Last Update
January 23 2024
Active Locations (1)
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1
CHU Grenoble Alpes
Grenoble, France, 38700