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Can small brain aneurysms be safely watched instead of treated?

NCT ID NCT07817511

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

About 600 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

May 2033

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.

Ages

35 to 75 years

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 : * 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.

brain aneurysm subarachnoid hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial aneurysm 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

    1 site. 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

  • Service de Neuroradiologie - Hôpital Lariboisière - APHP Nord

    Paris, Île-de-France Region, 75010, France

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