Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

Not Applicable

Recruiting

• Conditions: Wide Neck Bifurcation Intracranial Aneurysms

• Registration Number: NCT04839705
• Lead Sponsor: Microvention-Terumo, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Study Start: 2022-08-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 IRN 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 other intracranial hemorrhage within 90 days
• Patient index IA was previously treated
• Patient is pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Key Effectiveness Outcome	12 Months	Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome	12 Months	Proportion of subjects with death of any nonaccidental cause or any major stroke\* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment

Trial Locations

Locations (29)

Memorial Health Systems; 🇺🇸 Hollywood, Florida, United States

Orlando Health Neuroscience Institute; 🇺🇸 Orlando, Florida, United States

The Queen's Medical Center Neuroscience Institute; 🇺🇸 Honolulu, Hawaii, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Kansas Health System; 🇺🇸 Kansas City, Kansas, United States

Baptist Health Systems; 🇺🇸 Lexington, Kentucky, United States

University of Kentucky, Department of Neurosurgery; 🇺🇸 Lexington, Kentucky, United States

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States

LSU Health Sciences Center at Shreveport; 🇺🇸 Shreveport, Louisiana, United States

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

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