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Brain aneurysm study aims to predict rupture risk without surgery

NCT ID NCT04578808

Knowledge-focused Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows 1,000 people with small, unruptured brain aneurysms (3-7 mm) for three years. Researchers will use MRI scans to see if a specific imaging sign—wall enhancement—can predict which aneurysms grow. The goal is to create a safer, personalized monitoring plan so that only high-risk aneurysms get treated.

What this could mean

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

What this could lead to
If successful, this could lead to a personalized follow-up plan for people with unruptured brain aneurysms, reducing unnecessary treatments and anxiety.
What could go wrong
This is an observational study, not a treatment trial. It may not find a reliable predictor, and results may not apply to all aneurysm types or sizes.

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 1,000 people

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

Started

Aug 2019

Expected to finish

Mar 2031

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

The recruited population is composed of subjects carrying unruptured asymptomatic typical IA of bifurcation for whom a clinical, a biological and an imaging follow-up, without occlusion treatment, was scheduled by local multidisciplinary staff.

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 : * Subject carrying unruptured, asymptomatic and untreated typical IA of bifurcation, measured on conventional imaging (MRI, CTA or DSA) between 3 and 7 mm of larger diameter. * Ability to be followed-up during 3 years decided in consensus multidisciplinary gathering. * Age \> 18 years old. Exclusion Criteria : * A failure to obtain informed consent * Contraindications for undergoing an MRI scan include : (heart pacemaker, a metallic foreign body (metal sliver) in their eye, or aneurysm clip in their brain, severe claustrophobia) * Contraindications for a gadolinium contrast medium injection (:eGFR below 30 mL/min/1.73 m2, Previous or pre-existing nephrogenic systemic fibrosis, Previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, Acutely deteriorating renal function, Pregnancy and breast-feeding) * A mycotic, fusiform-shaped, or dissecting IA, an IA in relation with an arteriovenous malformation * A family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrom, fibromuscular dysplasia, or Moya Moya disease * Intra-cavernous UIA because the sinus cavernous that is fulfilled with venous blood precluded a reliable assessment of aneurysmal wall enhancement (AWE)

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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.

Unruptured 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

    28 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

  • AP-HP La Pitié-Salpêtrière Hospital

    RECRUITING

    Paris, Paris, 75000, France

  • AP-HP Le Kremlin Bicêtre Hospital

    RECRUITING

    Paris, Paris, 75000, France

  • Amiens University Hospital

    RECRUITING

    Amiens, Somme, 80000, France

  • Angers University Hospital

    RECRUITING

    Angers, Maine et Loire, 49000, France

  • Bordeaux University Hospital

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Brest University Hospital

    RECRUITING

    Brest, Finistère, 29200, France

  • CHU Dijon

    RECRUITING

    Dijon, France

  • CHU de Besançon

    RECRUITING

    Besançon, France

  • CHU de Caen

    RECRUITING

    Caen, France

  • CHU de Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • CHU de Poitiers

    RECRUITING

    Poitiers, France

  • CHU de Strasbourg

    RECRUITING

    Strasbourg, France

  • CHU de saint Etienne

    RECRUITING

    Saint-Etienne, France

  • Clairval's Hospital

    RECRUITING

    Marseille, Bouches-du-Rhône, 13000, France

  • Creteil University Hospital

    RECRUITING

    Créteil, Val-de-Marne, 94000, France

  • Hôpital Foch

    RECRUITING

    Suresnes, France

  • InselHospital Bern

    NOT_YET_RECRUITING

    Bern, 3000, Switzerland

  • Limoges University Hospital

    RECRUITING

    Limoges, Haute-Vienne, 87000, France

  • Nancy University Hospital

    RECRUITING

    Nancy, Meurthe-et-Moselle, 54000, France

  • Nantes University Hospital

    RECRUITING

    Nantes, Loire-Atlantique, 44000, France

  • Reims University Hospital

    NOT_YET_RECRUITING

    Reims, Marne, 51100, France

  • Rennes University Hospital

    RECRUITING

    Rennes, Ille-et-Vilaine, 35000, France

  • Rostchild Foundation Hospital

    RECRUITING

    Paris, Paris, 75000, France

  • Rouen University Hospital

    RECRUITING

    Rouen, Seine-Maritime, 76000, France

  • St Anne HIA

    RECRUITING

    Toulon, France

  • Ste Anne's Hospital

    RECRUITING

    Paris, Île-de-France Region, 75674, France

  • Toulouse University Hospital

    RECRUITING

    Toulouse, Haute-Garonne, 31000, France

  • Tours University Hospital

    RECRUITING

    Tours, Indre-et-Loire, 37000, France

  • UMC Utrecht

    COMPLETED

    Utrecht, 3500, Netherlands

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