The WEB-IT Clinical Study

Study Overview
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Brief Summary
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The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Official Title
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The WEB® Intrasaccular Therapy Study (WEB-IT)

Conditions
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Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms

Intervention / Treatment
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* Device: WEB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient whose age ≥18 and ≤75 years. Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment. Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures. Exclusion Criteria: Patient has an IA with characteristics unsuitable for endovascular treatment Patient has stroke-in-evolution within the prior 60 days Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days Patient's index IA was previously treated Patient is pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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>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>* The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.<br>* Other names: WEB Aneurysm Embolization Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365. | The study's primary safety endpoint was the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS)) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 days after treatment. | 12 months | 
| Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment | The primary effectiveness endpoint was defined as the percentage of subjects with complete aneurysm occlusion assessed using the WEB Occlusion Scale (WOS) without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment in the mITT population. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nervous System Diseases, Aneurysm, Intracranial Aneurysm, Vascular Diseases, Cardiovascular Diseases, Intracranial Arterial Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases