Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment

Inclusion criteria

• Patient is aged ≥18 years
• Patient has an unruptured or recanalized intracranial aneurysm :

• for which an endovascular treatment has been determined appropriate
• that can not be treated by standard techniques (coiling with or without remodeling)
• and for which the FRED® Flow Diverter has been determined an appropriate treatment
• Patient or patient's legally authorized representative has been informed about the confidentiality of the study and agrees to the collection of his/her personal data
• Patient presents with an mRS score between 0 and 2
• Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:

• the previous treatment was more than three months prior to enrollment in this study
• the aneurysm to be treated for this study is a new aneurysm located on a different parent vessel unless the stent already in place is implanted on the proximal carotid artery.

Exclusion criteria

• Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium
• Patient has contraindication to antiplatelet therapy and/or heparin
• Patient is pregnant and/or breastfeeding
• Patient may not benefit from imaging and clinical monitoring
• Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year
• Patient will be treated with a flow diverter other than FRED®
• Patient had an intracranial hemorrhage within the 30 days preceding treatment
• Patient has an aneurysm(s) with one or more of the following characteristics:

• associated with an arteriovenous malformation
• dissecting or ""blister-like""
• multiple (unless only one aneurysm requires treatment)
• located in the posterior circulation
• treated with a stent or a flow diverter on the same parent vessel (excluding proximal carotid artery) or in the 3 months prior to inclusion
• Patient has stenosis of the aneurysm parent artery.