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Massive brain aneurysm device registry launches to find best treatment

NCT ID NCT06174727

Knowledge-focused Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study looks back at medical records of up to 5,000 adults who had a brain aneurysm treated with special mesh tubes called flow diverters. Researchers want to see how well these devices work and how safe they are by checking things like successful placement, complications, and recovery. The goal is to learn which device works best for different types of aneurysms.

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.

Participants

About 5,000 people

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

Started

Oct 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients with intracranial aneurysms who underwent endovascular treatment with flow diverter stents or endosaccular flow disruptors

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.

Inclusion Criteria: * Consecutive adult patients (18 years of age or older) * Underwent endovascular treatment with one of the following devices: a. Endoluminal Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (Stryker Neurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X; MicroVention) viii. p64 Flow Modulation Device (phenox GmbH) ix. Endovascular clip system (eCLIPs) (eCLIPsTM, eVasc Neurovascular, Vancouver, BC, Canada) b. Intrasaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii. Luna/Artisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA) * Complete medical records and follow-up data available Exclusion Criteria: * Incomplete procedural or follow-up records * Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases) * Aneurysms treated with investigational devices not listed within Inclusion Criteria

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

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

Intracranial aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allina Health

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Geisinger Health

    COMPLETED

    Danville, Pennsylvania, 17822, United States

  • HCA Houston Healthcare Kingwood

    COMPLETED

    Kingwood, Texas, 77339, United States

  • Lahey Hospital and Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Mayo Clinic Florida

    COMPLETED

    Jacksonville, Florida, 32224, United States

  • Montefiore Medical Center Department of Neurosurgery

    RECRUITING

    The Bronx, New York, 10467, United States

  • Munson Medical Center

    RECRUITING

    Traverse City, Michigan, 49684, United States

  • Robert Wood Johnson University

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sarasota Memorial Research Institute

    COMPLETED

    Sarasota, Florida, 34239, United States

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Toronto Western Hospital

    RECRUITING

    Toronto, Ontario, M5T 2S8, Canada

  • University at Buffalo

    COMPLETED

    Buffalo, New York, 14068, United States

  • University of Miami

    RECRUITING

    Coral Gables, Florida, 33146, United States

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