This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.
Primary Endpoints: * Safety: Death or stroke in downstream territory to 180-days post-procedure * Technical Success: Device placement success and ability to retain coils at the time of the index procedure * Rate of aneurysm occlusion at Day zero (0) and 180 days Additional Evaluations to 180-days and at 365-day follow up: * Rate of aneurysm occlusion at 365 days * Device movement or migration * Stenosis * Rate of incidence of new neurological deficits * Complication rate (neurological and non-neurological)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Adjunctive device for endovascular embolization of intracranial aneurysms
Medical University of South Carolina
Charleston, South Carolina, United States
Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death
Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II. class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death.
Time frame: 180 days post procedure
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