Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment

This is a multi-center observational study. Treatment and follow-up visits will be done as per standard of care.

The purpose of this study is to demonstrate that use of the FRED/FRED Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure.

100 patients will be enrolled over an 18-month recruitment period. All patients will be followed for 12 months.

Inclusion criteria

• Patient older than 18 years old
• Patient harboring an unruptured intracranial aneurysm:

• for which endovascular treatment is indicated
• for which use of FRED or FRED Jr has been deemed appropriate
• being the only one to require treatment over the period of the study
• and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
• Patient with a modified Rankin Scale (mRS) ≤ 2
• Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form

Exclusion criteria

• Patient has suffered an ICH within the 30 days prior to the procedure.
• The aneurysm to be treated is associated with an cAVM
• The aneurysm to be treated is a dissecting or blister-like aneurysm
• The aneurysm to be treated or any other aneurysm is in the posterior circulation
• The aneurysm to be treated has a stenosis of its parent artery
• Patient has another aneurysm previously treated with a stent or a flow diverter

• on the same parent vessel at any time (except in the case of the proximal carotid if the treatment occurred more than 3 months prior to the procedure)
• on a different parent vessel, less than 3 months prior to the procedure
• Patient has another aneurysm requiring treatment within the study period
• Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
• Patient with a contra-indication to antiplatelet or heparin
• Pregnancy or child breastfeeding
• Patient unable or unlikely to complete required follow up
• Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
• Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.