Can a tiny mesh device defuse brain aneurysms? a registry investigates
NCT ID NCT07748572
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This study is a registry that will follow about 200 people with brain aneurysms who are treated with a flow diverter device (p64, p64 MW, or p48 MW). The goal is to see how safe and effective these devices are in real-world practice across France. Participants will be monitored for up to 12 months to track any complications and how well the device works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flow diverter device (p64, p64 MW, or p48 MW) used to treat intracranial aneurysms
- What this could lead to
- If successful, this registry could confirm that these flow diverters are safe and effective for treating brain aneurysms, potentially improving outcomes for patients.
- What could go wrong
- This is an observational registry, not a controlled trial, so it cannot prove the devices work better than other treatments. Risks include procedure-related complications like bleeding or blood clots.
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.
- Participants
-
About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The registry will include subjects across France who are treated for an intracranial aneurysm with a p64, p64 MW or p48 MW Flow Modulation Device.
- Ages
-
18 years and older
- 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 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: * 1\. Age ≥ 18 years and legally of age. * 2\. The patient has intracranial aneurysm(s) \* and is treated or planned to be treated with p64, p48 MW or p64 MW Devices. (\*cases of ruptured aneurysms in the context of a staged procedure or not treatable by another technique, and cases of multiple aneurysms are eligible) * 3\. The patient or his/her legal representative (in case the patient does not have the capacity due to his/her clinical condition), does not object to the collection and processing of the data specified in the protocol. Exclusion Criteria: * 1\. Participation in an interventional study modifying standard patient care management (e.g. COATING study) * 2\. State or circumstance that does not allow the patient to undergo the standard site's follow-up for aneurysm treatment
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Intracranial aneurysms are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
11 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
CHRU Strasbourg
RECRUITINGStrasbourg, 67091, France
-
CHU Amiens-Picardie
RECRUITINGAmiens, 80054, France
-
CHU Bordeaux
RECRUITINGBordeaux, 33076, France
-
CHU Clermont-Ferrand
RECRUITINGClermont-Ferrand, 63003, France
-
CHU Pierre Wertheimer
RECRUITINGBron, 69500, France
-
CHU Reims
RECRUITINGReims, 51092, France
-
CHU Rouen
RECRUITINGRouen, 76031, France
-
CHU Tours
RECRUITINGTours, 37044, France
-
CHU de Limoges
RECRUITINGLimoges, 87042, France
-
Hôpital Bicêtre
RECRUITINGLe Kremlin-Bicêtre, 94270, France
-
Hôpital Pitié-Salpêtrière
RECRUITINGParis, 75651, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- China builds national watchdog for brain blood vessel devices
- Brain aneurysm showdown: which coated stent causes fewer strokes?
- New coil aims to plug brain aneurysms more safely and cheaply
- New ultrasound spots metal in brain after aneurysm clipping
- Can a smart app make brain aneurysm Follow-Up better?
- AI to uncover hidden social risks for brain aneurysm patients