NCT02435823

Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms

Adjunctive Wide-neck Aneurysm Reconstruction Device Post Market Clinical Study Europe

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Pulsar Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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 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)

Conditions

• Brain Aneurysm

Interventions

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

Timeline

• Start date: 2015-03-31
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2015-05-06
• Last updated: 2019-02-07

Locations

1 site across 1 country: Austria