FRED and FRED JR Devices for Intracranial Aneurysm Treatment

Microvention-Terumo, Inc.135 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

135

Conditions

Intracranial Aneurysm

Interventions

FRED and FRED JRDEVICE

Intracranial aneurysm treatment

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

CHU Grenoble Alpes

Grenoble, France

Outcomes

Primary Outcomes

Mortality Rate

Percentage of patients with neurological death

Time frame: 1 year

Morbidity Rate

Percentage of patients with major ipsilateral stroke

Time frame: 1 year

Secondary Outcomes

modified Rankin Score

worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death)

Time frame: 1 year

Complete aneurysm occlusion rate

Measured by the Raymond Scale

Time frame: 1 year

Retreatment Rate

Rate and description of aneurysm retreated or planned for retreatment

Time frame: 1 year

Patient description

Description of the population of patients treated with FRED and FRED JR in France

Time frame: 1 year

Data from ClinicalTrials.gov

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