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Brain aneurysm device under Long-Term scrutiny

NCT ID NCT04839705

Disease control Sponsor: Microvention-Terumo, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 195 adults who received the WEB device, a mesh implant used to block blood flow into wide-neck brain aneurysms. Researchers are checking how well the device works and its safety over one year. The goal is to confirm that the device remains a reliable option for treating these aneurysms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
WEB device (a mesh implant used to block blood flow into brain aneurysms)
What this could lead to
If successful, this study could confirm that the WEB device is a safe and effective long-term option for treating certain brain aneurysms, reducing the need for more invasive surgery.
What could go wrong
This is an observational follow-up study, not a new treatment test. The device is already approved, so the main risk is that long-term results may show lower effectiveness or higher complication rates than expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 195 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Aneurysm brain aneurysm cerebrovascular disorder intracranial arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Wide neck bifurcation intracranial aneurysms

Contacts and locations

Locations

  • Abbott Northwestern Hospital Allina Health

    Minneapolis, Minnesota, 55407, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Baptist Health Systems

    Lexington, Kentucky, 40503, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103, United States

  • Massachusetts General Brigham Incorporated

    Boston, Massachusetts, 02114, United States

  • Memorial Health Systems

    Hollywood, Florida, 33021, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Northshore University Hospital/Northwell Health

    Manhasset, New York, 11030, United States

  • Norton Healthcare

    Louisville, Kentucky, 40241, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • OhioHealth Research Institute

    Columbus, Ohio, 43214, United States

  • Orlando Health Neuroscience Institute

    Orlando, Florida, 32806, United States

  • SUNY Stony Brook

    Stony Brook, New York, 11794, United States

  • Semmes Murphey

    Memphis, Tennessee, 38120, United States

  • The Queen's Medical Center Neuroscience Institute

    Honolulu, Hawaii, 96813, United States

  • The Toledo Hospital d/b/a ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • The Washington University

    St Louis, Missouri, 63110, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UMass Memorial Health

    Worcester, Massachusetts, 01655, United States

  • University of Buffalo

    Buffalo, New York, 14203, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Health System

    Kansas City, Kansas, 66160, United States

  • University of Kentucky, Department of Neurosurgery

    Lexington, Kentucky, 40536, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania Health Systems

    Philadelphia, Pennsylvania, 19104, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States