CompletedNot Applicable

The WEB-IT Clinical Study

United States150 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 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

Timeframe: 12 months

Trial details

NCT IDNCT02191618

SponsorMicrovention-Terumo, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09

Results submitted2020-02-18

View on ClinicalTrials.gov More Wide Neck Bifurcation Intracranial Aneurysms trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

Timeframe: 12 months