To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.
Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.
Barrow Neurological Institute
Phoenix, Arizona, United States
SUNY Stony Brook
Stony Brook, New York, United States
Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death.
Time frame: 180 days
Rate of complete target aneurysm occlusion
Time frame: 1, 3 and 5 years
Incidence of ipsilateral major stroke
Time frame: 180 days
Change in modified Rankin scale (MRS)
Time frame: 180 days, 1, 3 and 5 years
Incidence of device-related adverse events
Time frame: 180 days, 1, 3 and 5 years
Change from baseline in neurologic signs or symptoms related to the target aneurysm
Time frame: 180 days
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