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Clinical Trial Summary

This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02312856
Study type Interventional
Source Pulsar Vascular
Contact
Status Completed
Phase N/A
Start date October 31, 2014
Completion date October 30, 2016

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