The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.
Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
Age 18-80 years at screening
Patients who are suitable for non-emergency endovascular embolization of saccular IAs
IA located in bifurcation in the anterior or posterior circulation
Ruptured intracranial aneurysm
Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab
Contraindication for arterial access
Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm
Single group
LuSeed Aneurysm Embolization System
DeviceLuSeed Aneurysm Embolization System EFS Canada
Primary Safety Endpoint
Death of any non-accidental cause, Procedure or Device Related Death or Any Major Disabling Stroke \*An independent Medical Monitor (IMM) will adjudicate all data used for safety endpoint analyses
Primary Feasibility Endpoint
Technical Success as defined by: a. Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System b. Successful visual confirmation of the LuSeed Aneurysm Embolization System Successful deployment and detachment of the LuSeed Aneurysm Embolization System
Secondary Safety Endpoints
Percentage of participants with death of non-accidental cause or device related death, or major disabling stroke at 6 months and 12 months.
Secondary Safety Endpoints
Percentage of participants presenting each component of the safety composite within first 30 days after treatment, 6 months and 12 months
Secondary Safety Endpoints
Percentage of participants with serious adverse events within the first 30 days after treatment, 6 months and 12 months.
Secondary Effectiveness Endpoints
Proportion of subjects with Complete Aneurysm Occlusion immediate post procedure.
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