FRED and FRED JR Devices for Intracranial Aneurysm Treatment

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT04315168
• Lead Sponsor: Microvention-Terumo, Inc.

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 Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-06-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality Rate	1 year	Percentage of patients with neurological death
Morbidity Rate	1 year	Percentage of patients with major ipsilateral stroke

Secondary Outcome Measures

Name	Time	Method
modified Rankin Score	1 year	worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death)
Complete aneurysm occlusion rate	1 year	Measured by the Raymond Scale
Retreatment Rate	1 year	Rate and description of aneurysm retreated or planned for retreatment
Patient description	1 year	Description of the population of patients treated with FRED and FRED JR in France

Trial Locations

Locations (1)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France