Can small brain aneurysms be safely watched instead of treated?
NCT ID NCT07817511
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers compare two approaches for adults with small unruptured brain aneurysms found by chance: regular imaging surveillance without initial treatment, or immediate endovascular or surgical repair. The trial enrolls 600 adults aged 35 to 75 with aneurysms measuring 2 to 7.9 mm. Participants are randomly assigned to one strategy and followed for at least 42 months with annual brain imaging, quality-of-life questionnaires, and functional assessments. The main question is whether watchful waiting reduces the risk of lasting neurological disability compared with immediate treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- watchful waiting with regular imaging surveillance, compared with immediate endovascular or neurosurgical aneurysm treatment
- What this could lead to
- If watchful waiting proves safe, people with small aneurysms found by chance could avoid brain surgery or artery procedures and their risks.
- What could go wrong
- Some aneurysms may rupture during monitoring, and watchful waiting may not suit everyone. Results may not apply to larger or symptomatic aneurysms.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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May 2033
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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35 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 : * UIA (Unruptured Intracranial Aneurysms) located in an intradural position, with confirmed presence on CT (Computed Tomography) angiography or conventional cerebral angiography. * Largest diameter between 2 mm and 7.9 mm inclusive in height or width (excluding oblique measurements). * Patients with one or more UIAs, provided that at least one aneurysm (index aneurysm) fulfills all inclusion criteria and is selected for study evaluation. * Patients aged ≥ 35 years to 75 years. * Patients must have signed informed consent. * Patients must be affiliated with the French healthcare system. Exclusion Criteria : * Aneurysms deemed inoperable by endovascular or surgical techniques, and patients with absolute contraindications to anaesthesia. * Patients with a disease reducing life expectancy to less than 3 years. * Patients with a mRS score of ≥2. * Patients with a history of prior treatment for a cerebral aneurysm (ruptured or unruptured). * History of unexplained SAH (Subarachnoid Haemorrhage). * UIA discovered in the context of a recent thunderclap or exertional headache. * Fusiform, mycotic, or intracavernous UIAs. * Infundibulum of the posterior communicating artery (PcomA) and choroidal artery. * Very distal saccular UIAs: A3/A4, M3/M4, P3/P4. * UIA associated with brain AVM (Arteriovenous Malformation). * Patients presenting with multiple UIAs in whom at least one aneurysm measures ≥ 8 mm, in order to avoid inclusion of patients at higher overall rupture risk not compatible with the study population. * Pregnancy or a desire for pregnancy during the study period. * Patients with autosomal dominant polycystic kidney disease (ADPKD), hereditary connective tissue disorders (HCTDs), or sickle cell disease (SCD). * Current participation in another interventional research study. * Patients likely to fail to attend follow-up visits or adhere to the protocol. * Allergy to iodinated contrast material. * Severe renal impairment (Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2).
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Service de Neuroradiologie - Hôpital Lariboisière - APHP Nord
Paris, Île-de-France Region, 75010, France
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