ClinicalTrials.gg
RecruitingNCT04578808U-CANUpdated Sep 25, 2026

Unruptured Cerebral Aneurysm: Prediction of Evolution

An observational study in Unruptured Intracranial Aneurysm, sponsored by Nantes University Hospital. Recruiting at 29 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Nantes University Hospital · Observational

From the registry’s dates

  • Started Aug 2019; still recruiting 7 years 2 months later.
Updated Sep 25, 2026Site recruiting status changed1 site added+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 66 studies in Intracranial Aneurysm with a site in France — 20 open to participants now, 27 under way, 1 of them phase 3. Intracranial Aneurysm · France.

Planned enrollment
9th of 43
1,000 · median 206
Started
2019
with 4 others
Observational
43 of 66
10 open now
Primary completion
2031-03
later than 16 of 26 live
Registered
44th of 66
by date
Lead sponsor
6 of 66
Nantes University Hospital

Among the 66 studies in Intracranial Aneurysm with a site in France, this one is the 9th largest by planned enrollment of the 43 observational ones that give a count, is one of 5 that started in 2019, is one of 43 observational ones, reaches primary completion later than 16 of the 26 other live ones, and was the 44th registered.

Intracranial Aneurysm

418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.

Browse Intracranial Aneurysm studies →

Open to participants now

20 of the 66 studies in Intracranial Aneurysm with a site in France are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 66 studies in Intracranial Aneurysm with a site in France, or all of them as a file.
02

Study summary

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.

Read the detailed description

Management of small (\<7mm) unruptured intracranial aneurysms (UIA) remains controversial. Previous retrospective studies have suggested that post gadolinium arterial wall enhancement (AWE) of unruptured intracranial aneurysms on MR imaging may reflect aneurysm wall instability, and hence may highlight a higher risk of UIA growth over time. This multicentric prospective cohort aims at exploring vessel wall imaging findings of UIAs with consecutive follow-up to substantiate these assumptions.The objective is to develop diagnostic and predictive tools for the risk of IA evolution. The aim is to demonstrate in clinical practice the predictive value of (AWE) for UIA growth. The growth will be determined by any modification of the UIA measurement. Both UIA growth and the UIA wall enhancement will be assessed in consensus by two expert neuroradiologists.The French prospective UCAN project is a non-interventional international wide and multicentric prospective cohort. UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).

03

Conditions studied

  • Unruptured Intracranial Aneurysm

Browse trials for

Keywords

  • Unruptured Cerebral Aneurysm
  • Aneurysm Prediction Growth
  • Unruptured Intracranial aneurysm
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria :

  • A failure to obtain
  • 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 (: 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)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • OtherUnruptured intracranial aneurysms

    UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).

06

What researchers measure

Primary outcomes

  1. The aim is to evaluate in clinical practice the predictive value of UIA wall enhancement for UIA growth. It will allow to set up a secure, efficient and personalized follow-up.

    In order to evaluate the informative value of AWE for UIA growth, investigators will consider as primary endpoint the growth of the UIA after the complete follow-up at 3 years.

    Time frame: 5 years

  2. Predictive value of UIA wall enhancement for UIA growth

    This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with \> 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert.

    Time frame: at 1 year

  3. Predictive value of UIA wall enhancement for UIA growth

    This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with \> 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert.

    Time frame: at 3 years

Secondary outcomes

  1. Quality of life related to the growth of UIA.

    Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up.

    Time frame: 5 years

  2. AWE variation patterns related to the growth of UIA.

    Detection of other AWE variation patterns related to growth during the follow-up in order to improve the follow-up of UIA patients

    Time frame: 5 years

  3. Clinical, genetics or biological factors related to the growth of UIA.

    Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase…) features recorded.

    Time frame: 5 years

  4. Incidence of growth of UIA.

    Incidence of growth, stratified by clinical, genetics or biological features.

    Time frame: 5 years

  5. Incidence of IA rupture

    Incidence of IA rupture, stratified by clinical, genetics or biological features.

    Time frame: 5 years

  6. quality of life patients related to the growth of UIA.

    Completion of standardized EQ5D questionnaire to measure quality of life patients

    Time frame: 5 years

  7. Construction of an automatized tool of AWE pattern

    Construction and evaluation of an automatized tool of AWE patterns, as compared to the visual analysis of experts, in the form of a decision-making tool.

    Time frame: 5 years

07

Study locations

25 of 29 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2019 (actual). Primary completion is estimated for Mar 2031, 138 months after the start.

Of 67 non-industry observational studies under Intracranial Aneurysm, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 145. This study's planned 138 months is above that.

Counting every sponsor, half of 104 studies reached it within 46 months; a quarter within 36 and three quarters within 145.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2020
First posted
Oct 8, 2020
StartActual
Aug 19, 2019
Primary completionEst.
Mar 15, 2031
CompletionEst.
Mar 15, 2031
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed. Reims University Hospital is now Withdrawn
Show site
  • Hôpitaux Civils de Colmar · Colmar, France
Show 1 removed
  • Creteil University Hospital · Créteil, France
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    1 site added, 1 site removed. Reims University Hospital is now Withdrawn
    Show site
    • Hôpitaux Civils de Colmar · Colmar, France
    Show 1 removed
    • Creteil University Hospital · Créteil, France
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04578808
Responsible party
Sponsor
First posted
Oct 8, 2020
Start date
Aug 19, 2019
Primary completion
Mar 15, 2031 (estimated)
Completion
Mar 15, 2031 (estimated)
Last update
Sep 25, 2026

Study contacts

Romain BOURCIER, MD
Contact
romain.bourcier@chu-nantes.fr
33240165608
Romain BOURCIER, MD
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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