FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study

This is a multi-center observational study. Treatment and follow-up visits will be performed as per standard of care. The purpose of this study is to demonstrate that use of the FRED/ FRED Jr/ FRED X Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure.

150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.

Inclusion criteria

• Patient older than 18 years old
• Patient harboring a non-acutely ruptured intracranial aneurysm within the last 30 days of presentation:

• for which use of FRED, FRED Jr or FRED X has been deemed appropriate
• being the only aneurysm to require treatment within the next 12 months
• and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
• Patient with a modified Rankin Scale (mRS) ≤ 2
• Patient has received information about data collection and has signed and dated an Informed Consent Form

Exclusion criteria

• Patient has suffered from an ICH within the 30 days prior to the procedure.
• The aneurysm to be treated is associated with a cAVM
• The aneurysm to be treated is in the posterior circulation
• The aneurysm to be treated has a stenosis of its parent artery >50%
• Patient has another aneurysm previously treated with a stent or a flow diverter

• on the same parent vessel at any time
• on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable)
• Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient
• Patient with known hypersensitivity to contrast products or nickel titanium, not treatable
• 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/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned