Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms (FRED)
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The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
Proportion of subjects who experience neurological death or major ipsilateral stroke measured by the modified Rankin Scale(mRS)and the National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 12 months ]
Secondary Outcome Measures :
Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ]
Other Outcome Measures:
Proportion of subjects with complete occlusion of the target aneurysm and ≤50% stenosis of the parent artery [ Time Frame: 12 months ]
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Layout table for eligibility information
Ages Eligible for Study:
22 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject whose age≥ 22and ≤75 years
Subject has single target aneurysm located in the internal carotid artery
Subject fulfills study requirements and his/her legally authorized representative provides a signed informed consent form
Subject who suffers from an intracranial hemorrhage in the last 30 days
Subject who suffers from a subarachnoid hemorrhage in the last 60 days
Subject with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and nexk region
Subject who is pregnant or breastfeeding
Subject has an arteriovenous malformation (AVM)in the area of the target aneurysm