N/A
N=150
The WEB-IT Clinical Study
Wide Neck Bifurcation Intracranial Aneurysms · Intracranial Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT02191618 ↗Enrolled (actual)
150
Serious AEs
22.0%
Results posted
Apr 2020
Primary outcome: Primary: 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. — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WEB (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Microvention-Terumo, Inc.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
1 | — |
| PRIMARY 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 |
77 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02191618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.