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Evaluating the long-term safety and effectiveness of the WEB device for treating wide neck bifurcation intracranial aneurysms

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

Not applicable Interventional Microvention-Terumo, Inc. · NCT04839705

This study is testing if the WEB device is a safe and effective way to treat wide neck bifurcation brain aneurysms in adults over the long term.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorMicrovention-Terumo, Inc. Industry-sponsored
Locations27 sites (Hollywood, Florida and 26 other locations)
Trial IDNCT04839705 on ClinicalTrials.gov

What this trial studies

This interventional study aims to assess the long-term safety and effectiveness of the WEB device in treating wide neck bifurcation intracranial aneurysms in adult patients. It is a prospective, multicenter, single-arm study that will evaluate the adequacy of aneurysm occlusion one year after treatment, as determined by a core laboratory. Participants will include adults with either ruptured or unruptured aneurysms requiring treatment, and they will be monitored for safety and effectiveness outcomes over time.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a single ruptured or unruptured intracranial aneurysm that requires treatment.

Not a fit: Patients with aneurysms unsuitable for endovascular treatment or those with recent ischemic symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with wide neck bifurcation intracranial aneurysms.

How similar studies have performed: Other studies have shown promising results with similar endovascular approaches, indicating potential for success in this study.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Hollywood, Florida and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Wide Neck Bifurcation Intracranial AneurysmsAneurysmIntracranial Arterial DiseaseCerebrovascular Disorders
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.