Brain Aneurysm Clinical Trial
Official title:
Adjunctive Wide-neck Aneurysm Reconstruction Device Post Market Clinical Study Europe
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial 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 within the aneurysm (as judged by the
treating physician at the time of the procedure. Core lab will review images at a later time)
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 defined as any relative change in the position of the
device with respect to the parent and/or daughter vessels that is greater than 2mm by
conventional catheter angiography, CTA or MRA (180 days) and (365 days) Stenosis defined as
>50% at implant site by conventional catheter angiography, MRA or CTA at 180 days and at 365
days Rate of incidence of new neurological deficits Complication rate (neurological and
non-neurological)
;
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