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NCT04578808From ClinicalTrials.govRecruiting

Unruptured Cerebral Aneurysm: Prediction of Evolution

  • Unruptured Intracranial Aneurysm

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Nantes University Hospital
Enrolment target
1,000
Started
19 August 2019
Main results due
15 March 2031
Study sites
29
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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)

What this study is about

In the sponsor’s own words, from the registry.

The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.

Study sites(29)

  • Clairval's Hospital

    Marseille, Bouches-du-Rhône, France

    Recruiting

  • Brest University Hospital

    Brest, Finistère, France

    Recruiting

  • Bordeaux University Hospital

    Bordeaux, Gironde, France

    Recruiting

  • Toulouse University Hospital

    Toulouse, Haute-Garonne, France

    Recruiting

  • Limoges University Hospital

    Limoges, Haute-Vienne, France

    Recruiting

  • Rennes University Hospital

    Rennes, Ille-et-Vilaine, France

    Recruiting

  • Tours University Hospital

    Tours, Indre-et-Loire, France

    Recruiting

  • Nantes University Hospital

    Nantes, Loire-Atlantique, France

    Recruiting

  • Angers University Hospital

    Angers, Maine et Loire, France

    Recruiting

  • Reims University Hospital

    Reims, Marne, France

    Withdrawn

  • Nancy University Hospital

    Nancy, Meurthe-et-Moselle, France

    Recruiting

  • AP-HP La Pitié-Salpêtrière Hospital

    Paris, Paris, France

    Recruiting

  • AP-HP Le Kremlin Bicêtre Hospital

    Paris, Paris, France

    Recruiting

  • Rostchild Foundation Hospital

    Paris, Paris, France

    Recruiting

  • Rouen University Hospital

    Rouen, Seine-Maritime, France

    Recruiting

  • Amiens University Hospital

    Amiens, Somme, France

    Recruiting

  • CHU de Besançon

    Besançon, France

    Recruiting

  • CHU de Caen

    Caen, France

    Recruiting

  • CHU de Clermont Ferrand

    Clermont-Ferrand, France

    Recruiting

  • Hôpitaux Civils de Colmar

    Colmar, France

    Not yet recruiting

  • CHU Dijon

    Dijon, France

    Recruiting

  • CHU de Poitiers

    Poitiers, France

    Recruiting

  • CHU de saint Etienne

    Saint-Etienne, France

    Recruiting

  • CHU de Strasbourg

    Strasbourg, France

    Recruiting

  • Hôpital Foch

    Suresnes, France

    Recruiting

  • St Anne HIA

    Toulon, France

    Recruiting

  • Ste Anne's Hospital

    Paris, Île-de-France Region, France

    Recruiting

  • UMC Utrecht

    Utrecht, Netherlands

    Completed

  • InselHospital Bern

    Bern, Switzerland

    Not yet recruiting

Showing 29 of 29 sites. 25 of the 29 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04578808. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Unruptured Cerebral Aneurysm: Prediction of Evolution | Trialion