A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm

Phase 3

Terminated

Brief Summary: This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.

Detailed Description: The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.

Recruitment & Eligibility

Inclusion Criteria

Subject with wide neck intracranial aneurysm located at a bifurcation
The subject is between 18 and 80 years of age the time of consent
Informed consent is obtained and the subject signs the IRB approved consent prior to beginning any study procedures
In the opinion of the treating physician, placement of the PulseRider® device is technically feasible and clinically indicated

Exclusion Criteria

Unstable neurological deficit (condition worsening within the last 90 days)
Subarachnoid Hemorrhage (SAH) within the last 60 days
Irreversible bleeding disorder
Patient has another intracranial aneurysm that in the Investigator's opinion, may require treatment within the 1 year follow up period
A history of contrast allergy that cannot be medically controlled
Known allergy to nickel
Relative contraindication to angiography
Woman of child-bearing potential who cannot provide a negative pregnancy test
Current involvement in a study for another investigational product
Patient and / or family considering a move from this geographical location at the time of consent
Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)

Arm && Interventions

Group	Intervention	Description
Treatment Group	PulseRider® Aneurysm Neck Reconstruction Device	PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure	Up to 1 year post procedure	Number of participants with complete aneurysm occlusion (Raymond I: complete occlusion) without significant parent artery stenosis (greater than \[\>\] 50 percent \[%\] stenosis) or prior retreatment through 1-year post procedure were reported.
Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC)	Up to 1 year post procedure	Percentage of participants with occurrence of neurological death or major ipsilateral stroke in downstream territory up to 1 year post-procedure per CEC were reported. Major stroke is defined as stroke with symptoms persisting for more than 24 hours and a sudden increase in the National Institutes of Health Stroke Scale (NIHSS) of the subject by greater than or equal to (\>=) 4. Major ipsilateral stroke is major stroke in downstream territory.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Target Aneurysms Retreatment	Up to 1 year	Number of participants with target aneurysms retreatment were reported.
Number of Participants With Adequate Aneurysm Occlusion	1 year	Number of participants with adequate aneurysm occlusion were reported.
Number of Participants With Modified Rankin Scale (mRS) 0-2	1 year	Number of participants with modified rankin scale (mRS) 0-2 were reported. The mRS is a scale commonly used to measure the degree of disability or dependence in the daily activities in patients following stroke or other neurologic event and is conducted by qualified personnel. It is a scale with six categories ranging from no symptoms to severe disability and death.
Number of Participants With Technical Success of Successful Implantation of the PulseRider Device	Up to 1 year	Technical success was defined as successful implantation of the PulseRider device- the ability to access the target aneurysm, deploy the device at the aneurysm neck, and detach device successfully. Number of participants with technical success were reported.
Number of Participants With Significant Stenosis (>50%) at Implant Site	Up to 1 year	Number of participants with significant stenosis (\>50%) at implant site were reported.

Locations (2): Mount Sinai Hospital
🇺🇸
New York, New York, United States
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States