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Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Patient must be ≥ 18 at the time of screening * Patient must have a single ruptured or unruptured IA requiring treatment * Patient must sign and date an IRB-approved written informed consent prior to initiation of any study procedures Key Exclusion Criteria: * Patient has an IA with characteristics unsuitable for endovascular treatment * Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days * Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 90 days * Patient's index IA was previously treated * Patient is pregnant
About the study
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
What is being tested
- WEB (device)
Sponsor: Microvention-Terumo, Inc. · Participants: 200 · Started: Aug 24, 2022
Contact the study team
- Robert Gash · Phone: 908-914-1045
Official record on ClinicalTrials.gov — NCT04839705
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.