The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Flow Re-Direction Endoluminal Device
death or major stroke
A major stroke is defined as a new neurological event that persists for \> 24 hours and results in a mRS \>2. A minor stroke is defined as a new neurological event that persists for \> 24 hours.
Time frame: within 30 days post procedure
neurological death or major ipsilateral stroke, measured by mRS.
Time frame: within 6 months post procedure
Incidence of FRED System and procedure related Serious Adverse Events;
Time frame: 1 year
Incidence of successful delivery of the FRED System implant;
Time frame: 24 hours
Incidence of migration of the FRED System implant
Time frame: 6 months
Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject)
Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject
Time frame: Within 6 months
Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)
as measured by an increase in the modified Rankin Scale compared to baseline
Time frame: 6 months
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