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

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

Detailed Description
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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.

Official Title
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A Prospective, Multi-center, Single Arm Study to Evaluate 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

Conditions
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Unruptured Wide-neck Intracranial Aneurysms

Intervention / Treatment
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* Device: PulseRider® Aneurysm Neck Reconstruction Device


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms. | Device: PulseRider® Aneurysm Neck Reconstruction Device<br>* Neck Reconstruction Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 1 year post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 
| Number of Participants With Target Aneurysms Retreatment | Number of participants with target aneurysms retreatment were reported. | 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. | Up to 1 year | 
| Number of Participants With Adequate Aneurysm Occlusion | Number of participants with adequate aneurysm occlusion were reported. | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unruptured, intracranial aneurysms, Endovascular