Actively Recruiting
Unruptured Cerebral Aneurysm: Prediction of Evolution
Led by Nantes University Hospital · Updated on 2026-04-13
1000
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
C
Centre Hospitalier St Anne
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand unruptured intracranial aneurysms (UIA), specifically those measuring between 3 and 7 mm at bifurcation points. It explores the use of arterial wall enhancement (AWE) seen on MR imaging as a potential marker for aneurysm wall instability and the risk of aneurysm growth. The study is a large, prospective, multicenter observational cohort designed to combine detailed clinical, genetic, biological, and imaging data to develop tools predicting UIA evolution. Participants with small, untreated UIAs will be followed without occlusion treatment. Clinical and imaging data, including vessel wall imaging, will be collected at baseline and during follow-up visits at 1 and 3 years. The study involves extensive monitoring but no intervention, focusing on observing natural progression and imaging changes over three years. Participants will undergo clinical assessments, biological tests, and repeated imaging during the 3-year follow-up. Two expert neuroradiologists will assess aneurysm growth and wall enhancement in consensus. The primary goal is to evaluate the predictive value of AWE for aneurysm growth, with additional outcomes including quality of life and genetic or biological factors. The study will enable personalized follow-up planning and continuous data collection until study completion in 2031.
CONDITIONS
Brief Title
Unruptured Cerebral Aneurysm: Prediction of Evolution
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Carrying an unruptured, asymptomatic, untreated intracranial aneurysm of bifurcation measuring between 3 and 7 mm confirmed by MRI, CTA, or DSA
- Ability to attend and complete a 3-year clinical and imaging follow-up as decided by a multidisciplinary team
You will not qualify if you...
- Unable to provide informed consent
- Contraindications to MRI (e.g., pacemaker, metallic foreign body in eye, aneurysm clip in brain, severe claustrophobia)
- Contraindications to gadolinium contrast (e.g., low kidney function, previous severe allergic reaction, pregnancy, or breastfeeding)
- Presence of mycotic, fusiform, or dissecting aneurysms or aneurysms related to arteriovenous malformation
- Family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrome, fibromuscular dysplasia, or Moya Moya disease
- Intra-cavernous aneurysms due to unreliable assessment of wall enhancement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At inclusion
Imaging and clinical assessments are performed to evaluate unruptured intracranial aneurysms and their characteristics.
1 visit (in-person)
Duration - 3 years
Participants are monitored with clinical and imaging follow-up to assess aneurysm growth and wall enhancement over time.
Visits at 1 year and 3 years after inclusion
Trial Site Locations
Total: 21 locations
1
Clairval's Hospital
Marseille, Bouches-du-Rhône, France, 13000
Actively Recruiting
2
Brest University Hospital
Brest, Finistère, France, 29200
Actively Recruiting
3
Bordeaux University Hospital
Bordeaux, Gironde, France, 33000
Actively Recruiting
4
Toulouse University Hospital
Toulouse, Haute-Garonne, France, 31000
Actively Recruiting
5
Limoges University Hospital
Limoges, Haute-Vienne, France, 87000
Actively Recruiting
6
Rennes University Hospital
Rennes, Ille-et-Vilaine, France, 35000
Actively Recruiting
7
Tours University Hospital
Tours, Indre-et-Loire, France, 37000
Actively Recruiting
8
Nantes University Hospital
Nantes, Loire-Atlantique, France, 44000
Actively Recruiting
9
Angers University Hospital
Angers, Maine et Loire, France, 49000
Actively Recruiting
10
Reims University Hospital
Reims, Marne, France, 51100
Not Yet Recruiting
11
Nancy University Hospital
Nancy, Meurthe-et-Moselle, France, 54000
Actively Recruiting
12
AP-HP La Pitié-Salpêtrière Hospital
Paris, Paris, France, 75000
Actively Recruiting
13
AP-HP Le Kremlin Bicêtre Hospital
Paris, Paris, France, 75000
Actively Recruiting
14
Rostchild Foundation Hospital
Paris, Paris, France, 75000
Actively Recruiting
15
Rouen University Hospital
Rouen, Seine-Maritime, France, 76000
Actively Recruiting
16
Amiens University Hospital
Amiens, Somme, France, 80000
Actively Recruiting
17
Creteil University Hospital
Créteil, Val-de-Marne, France, 94000
Not Yet Recruiting
18
St Anne HIA
Toulon, France
Actively Recruiting
19
Ste Anne's Hospital
Paris, Île-de-France Region, France, 75674
Actively Recruiting
20
UMC Utrecht
Utrecht, Netherlands, 3500
Actively Recruiting
21
InselHospital Bern
Bern, Switzerland, 3000
Not Yet Recruiting
Research Team
R
Romain BOURCIER, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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