NCT02312856

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Pulsar Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Intracranial Aneurysms

Interventions

Type	Name	Description
DEVICE	PulseRider	Adjunctive device for endovascular embolization of intracranial aneurysms

Timeline

• Start date: 2014-10-31
• Primary completion: 2015-10-13
• Completion: 2016-10-30
• First posted: 2014-12-09
• Last updated: 2019-04-17
• Results posted: 2019-03-26

Locations

1 site across 1 country: United States