The WEB-IT Clinical Study

Not Applicable

Completed

Conditions: Intracranial Aneurysms
Wide Neck Bifurcation Intracranial Aneurysms

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
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.	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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (32): Barrow Neurological Institute
🇺🇸
Phoenix, Arizona, United States
Sequent Medical
🇺🇸
Aliso Viejo, California, United States
Radiology Imaging Associates P.C.
🇺🇸
Englewood, Colorado, United States
Lyerly Baptist, Inc
🇺🇸
Jacksonville, Florida, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Scroll for more (22 remaining)
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States