Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Study Overview
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Brief Summary
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A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Official Title
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Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Conditions
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Wide Neck Bifurcation Intracranial Aneurysms

Intervention / Treatment
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* Device: WEB


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patient must be ≥ 18 at the time of screening Patient must have a single ruptured or unruptured IA requiring treatment Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures Key Exclusion Criteria: Patient has an IA with characteristics unsuitable for endovascular treatment Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days Patient index IA was previously treated Patient is pregnant

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: WEB Aneurysm Embolization Device<br>WEB Aneurysm Embolization Device The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant. | Device: WEB<br>* Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key Effectiveness Outcome | Proportion of subjects with adequate aneurysm occlusion at one year after treatment. | 12 Months | 
| Key Safety Outcome | Proportion of subjects with death of any nonaccidental cause or any major stroke* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aneurysm, Intracranial Arterial Disease, Cerebrovascular Disorders