This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Neck Reconstruction Device
University of Kansas Medical Center
Kansas City, Kansas, United States
Mount Sinai Hospital
New York, New York, United States
Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 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.
Time frame: 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 Clinical Events Committee (CEC)
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.
Time frame: Up to 1 year post procedure
Number of Participants With Technical Success of Successful Implantation of the PulseRider Device
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.
Time frame: Up to 1 year
Number of Participants With Target Aneurysms Retreatment
Number of participants with target aneurysms retreatment were reported.
Time frame: Up to 1 year
Number of Participants With Significant Stenosis (>50%) at Implant Site
Number of participants with significant stenosis (\>50%) at implant site were reported.
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Time frame: Up to 1 year
Number of Participants With Adequate Aneurysm Occlusion
Number of participants with adequate aneurysm occlusion were reported.
Time frame: 1 year
Number of Participants With Modified Rankin Scale (mRS) 0-2
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.
Time frame: 1 year