The WEB-IT Clinical Study

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.

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Key information

Conditions

Wide Neck Bifurcation Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Aneurysms Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal University Hospital, Saskatoon, Saskatchewan, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WEB

Device

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.

Other names: WEB Aneurysm Embolization Device

Primary outcomes

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.

Time frame: 12 months

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.
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

Time frame: 12 months

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.

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

The WEB® Intrasaccular Therapy Study (WEB-IT)

Acronym: WEB-IT

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2023
First posted: Jul 16, 2014
Registry last updated: Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting