Not yet recruitingNAINTERVENTIONAL

Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms

This study is looking into a new way to prepare for treating a type of brain swelling called an aneurysm. Doctors plan to use 3D printers to create an exact model of a patient's aneurysm. By practicing on this model, they hope to get a better understanding of potential difficulties and ensure the real procedure goes smoothly. Currently, many aneurysms are treated by a 'minimally invasive' method where tiny coils or stents are placed inside the aneurysm to stop it from bursting. This study aims to make this already advanced treatment even safer by allowing doctors to plan and practice beforehand, reducing the chance of problems during the actual operation. Participants in the study will have this extra planning step, while others will receive standard care.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Brest

Enrolment target

Start

01 Dec 2026

Estimated completion

01 Jun 2029

Aneurysm Cerebral

What is this study about?

Imagine you have a tiny balloon-like bulge on a blood vessel in your brain – this is called a cerebral aneurysm. If it bursts, it can be very dangerous. Thankfully, doctors can often treat these using a special technique. They guide tiny wires and tools through your blood vessels, usually starting from your leg, all the way up to your brain. Then, they place small coils or stents inside the aneurysm to seal it off and prevent it from rupturing. This is a very common and effective treatment for many people.

However, every aneurysm is unique, and sometimes their shape and location can make the procedure tricky. Doctors want to make this treatment as safe and successful as possible. That's where this study comes in. They are exploring a clever new idea: using 3D printers to create a life-like model of a patient's exact aneurysm *before* the actual operation.

By having a realistic 3D model, surgeons can practice the procedure, try out different tools, and mentally prepare for any challenges they might face. The aim is to anticipate and solve potential problems in advance, outside of the operating room. This extra planning step could help make the real procedure smoother, quicker, and ultimately safer for patients, reducing the chance of unexpected issues during treatment.

Key takeaways

Aneurysms are treated to prevent them from bursting.
This study uses 3D printed models to help doctors practice.
The goal is to make aneurysm treatment safer and more precise.
Participation involves about 6 months of involvement.
It's a way to improve already advanced medical procedures.

Who may be eligible?

To be part of this study, you need to be an adult over 18 and be covered by social security. You must have an unburst aneurysm in a specific part of your brain (called carotid-sylvian) that measures between 4mm and 20mm. Doctors must have already decided that you need treatment for this aneurysm, and you should have had a special scan called a 3DRA recently, or have one planned soon.

There are also some reasons why you might not be able to join. For example, if you have certain allergies (like to the dye used in scans), kidney problems, or a very limited life expectancy. You also can't be pregnant, breastfeeding, or planning to become pregnant within a year. If you're physically unable to attend follow-up appointments, or if your aneurysm has already been treated or has certain features like being partially calcified, you won't be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Do you have a specific type of unburst brain aneurysm (carotid-sylvian) between 4mm and 20mm?
Have your doctors decided you need treatment for this aneurysm?
Do you not have severe kidney problems or specific allergies (e.g., to dye)?
Are you not pregnant, breastfeeding, or planning to be pregnant in the next year?
Can you attend all follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the total time you would be involved is about 6 months. This includes up to two months between your first visit and your aneurysm treatment. After your treatment, you will have follow-up appointments for about four months. You'll have an initial visit where a team member will explain the study and answer your questions. You'll then have a week to think about it before confirming if you want to participate. For some participants, a special 3D printed model of their aneurysm will be made and used by their doctors for practice before the actual procedure. All participants will undergo the standard aneurysm treatment and then have follow-up checks to see how they are doing.

Potential risks and benefits

Participating in this study might offer the benefit of your medical team having extra preparation for your procedure, potentially making it safer. However, like any medical treatment or study, there can be potential risks, though these are not fully detailed here. These could include minor discomforts from extra appointments or the very rare chance of unforeseen side effects. Remember, you can always change your mind and withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Pr Gentric Jean-Christophe
Verified postcode
Brest, France

Common questions

What is an aneurysm?

An aneurysm is like a small bulge or balloon on a blood vessel, usually in the brain. If it bursts, it can cause serious problems.

What is the main goal of this study?

The study aims to see if practicing on a 3D printed model of a patient's aneurysm before surgery helps make the actual procedure safer and smoother.

Will I definitely have a 3D model made for my procedure?

Not all participants will. The study will compare patients who have this extra planning step with those who receive standard care.

How long will I be in the study?

The study lasts around 6 months in total for each person, including follow-up appointments after treatment.

What is 'minimally invasive' treatment?

It's a modern way of treating conditions using small cuts or openings, like guiding tiny tools through blood vessels rather than major surgery.

How to find out more

Samuel GUIGO

samuel.guigo@chu-brest.fr +330298347532 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.