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Can a tiny mesh device defuse brain aneurysms? a registry investigates

NCT ID NCT07748572

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study is a registry that will follow about 200 people with brain aneurysms who are treated with a flow diverter device (p64, p64 MW, or p48 MW). The goal is to see how safe and effective these devices are in real-world practice across France. Participants will be monitored for up to 12 months to track any complications and how well the device works.

What this could mean

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

Active substance
Flow diverter device (p64, p64 MW, or p48 MW) used to treat intracranial aneurysms
What this could lead to
If successful, this registry could confirm that these flow diverters are safe and effective for treating brain aneurysms, potentially improving outcomes for patients.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the devices work better than other treatments. Risks include procedure-related complications like bleeding or blood clots.

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 200 people

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

Started

Mar 2025

Expected to finish

Dec 2028

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.

Who is studied

The registry will include subjects across France who are treated for an intracranial aneurysm with a p64, p64 MW or p48 MW Flow Modulation Device.

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: * 1\. Age ≥ 18 years and legally of age. * 2\. The patient has intracranial aneurysm(s) \* and is treated or planned to be treated with p64, p48 MW or p64 MW Devices. (\*cases of ruptured aneurysms in the context of a staged procedure or not treatable by another technique, and cases of multiple aneurysms are eligible) * 3\. The patient or his/her legal representative (in case the patient does not have the capacity due to his/her clinical condition), does not object to the collection and processing of the data specified in the protocol. Exclusion Criteria: * 1\. Participation in an interventional study modifying standard patient care management (e.g. COATING study) * 2\. State or circumstance that does not allow the patient to undergo the standard site's follow-up for aneurysm treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    11 sites. 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

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, 67091, France

  • CHU Amiens-Picardie

    RECRUITING

    Amiens, 80054, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, 33076, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63003, France

  • CHU Pierre Wertheimer

    RECRUITING

    Bron, 69500, France

  • CHU Reims

    RECRUITING

    Reims, 51092, France

  • CHU Rouen

    RECRUITING

    Rouen, 76031, France

  • CHU Tours

    RECRUITING

    Tours, 37044, France

  • CHU de Limoges

    RECRUITING

    Limoges, 87042, France

  • Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, 75651, France

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