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NCT04315168 Clinical Trial

FRED and FRED JR Devices for Intracranial Aneurysm Treatment

Intracranial Aneurysm Clinical Trial

Official title:
Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04315168
Other study ID # FRED-EPI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 12, 2020
Est. completion date December 31, 2023

Study information
Verified date January 2024
Source Microvention-Terumo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• FRED and FRED JR
Intracranial aneurysm treatment

Locations
Country Name City State
France CHU Grenoble Alpes Grenoble

Sponsors (1)
Lead Sponsor Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Rate Percentage of patients with neurological death 1 year
Primary Morbidity Rate Percentage of patients with major ipsilateral stroke 1 year
Secondary modified Rankin Score worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death) 1 year
Secondary Complete aneurysm occlusion rate Measured by the Raymond Scale 1 year
Secondary Retreatment Rate Rate and description of aneurysm retreated or planned for retreatment 1 year
Secondary Patient description Description of the population of patients treated with FRED and FRED JR in France 1 year
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