Intracranial Aneurysms Clinical Trial
Official title:
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and
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)
;
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