Not yet recruitingOBSERVATIONAL

Safety and EffecTiveness of the Silk Vista Flow DiverteR in the TrEatment of Unruptured IntracrAnial AneurysMs

This study is investigating a special device called the Silk Vista Flow Diverter, used to treat brain aneurysms that haven't burst yet. Brain aneurysms are weak spots in blood vessels in your brain that can bulge out. If they burst, they can cause serious problems. This device helps redirect blood flow away from the aneurysm, encouraging it to heal. Doctors want to understand how well this device works and if it stays in good shape over time. Sometimes, these devices can change shape, and this study aims to see if this happens with the Silk Vista and what impact it might have on patients’ health. The goal is to make treatments safer and more effective for people with these conditions.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Bordeaux

Enrolment target

100

Start

01 Sep 2025

Estimated completion

01 Dec 2027

Ruptured and Unruptured Intracranial Aneurysms

What is this study about?

Imagine a tiny bubble forming on the side of a garden hose. That's a bit like a brain aneurysm – a weak spot in a blood vessel in your brain that bulges out. Most of the time, these aneurysms don't cause any problems, especially if they haven't burst (these are called 'unruptured'). However, there's a risk they could burst, which can be very serious and sometimes life-threatening.

Doctors often treat these unruptured aneurysms to prevent them from bursting. One way to treat them is using a special device called a 'flow diverter stent'. Think of it as a tiny mesh tube that doctors carefully place inside the blood vessel, across the opening of the aneurysm. This device helps to redirect the blood flow away from the aneurysm, encouraging it to shrink and heal over time. This particular study is focusing on a device called the Silk Vista Flow Diverter.

The main purpose of this study is to gather more information about how well the Silk Vista device works and how safe it is for patients with unruptured brain aneurysms. Doctors have noticed that sometimes these types of devices can change shape or become a bit distorted after they’ve been put in, and we don't fully understand why this happens or what effect it has. By taking part, you would help researchers learn more about the Silk Vista and how it performs over time, which could lead to better treatments for future patients.

Key takeaways

The study investigates a device (Silk Vista Flow Diverter) for unruptured brain aneurysms.
It aims to understand the device's safety, effectiveness, and how its shape might change over time.
Participation involves treatment with the device and regular follow-up appointments and scans.
The study helps improve future treatments for brain aneurysms.
You can withdraw from the study at any point without affecting your care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old. You must have at least one brain aneurysm that hasn't burst, or one that burst more than 30 days ago, that your doctor plans to treat using the Silk Vista device. It's also important that you are able and willing to attend all scheduled appointments for scans and check-ups, and that you can give your informed consent to participate.

There are several reasons why you might not be able to join. For example, if you have a known allergy to certain metals (like nickel or titanium) or to the dye used in scans, or if you have certain medical conditions that make blood thinners unsafe for you. If you've had major surgery recently or are pregnant or breastfeeding, you also won't be able to take part.

Also, if your aneurysm is in a specific spot called a 'true bifurcation' or if the blood vessels leading to it are too twisted or narrow, you might not be suitable. The study also cannot include you if you've already had treatment for the specific aneurysm being studied in a way that would interfere with the device, or if you've had certain types of bleeding in your brain recently.

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 between 18 and 80 years old?
Do you have an unruptured brain aneurysm, or one that burst over 30 days ago, that needs treatment?
Are you able and willing to attend all study appointments and scans?
Do you have any severe allergies to metals (like nickel or titanium) or scan dyes?
Are you pregnant or breastfeeding?
Have you had major bleeding in your brain or major surgery recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your brain aneurysm treated with the Silk Vista Flow Diverter. After the procedure, you will have regular follow-up appointments, which will include scans (like MRI or CT scans) to check on the device and your aneurysm, as well as general health check-ups. These appointments will help doctors monitor how the device is working and if there are any changes over time. You will need to take antiplatelet medication, which helps prevent blood clots, as prescribed by your doctor. The exact number of visits and the total length of your participation will be explained by the study team, but typically, studies like this involve follow-ups over several months to a few years.

Potential risks and benefits

Taking part in this study means you will receive treatment for your unruptured brain aneurysm, which could help prevent it from bursting. You will also receive careful monitoring and follow-up care. However, as with any medical procedure, there are potential risks, including those associated with the device placement, medication, and the possibility of the device changing shape or causing other issues. Your participation also helps advance medical knowledge, potentially leading to better treatments for others in the future. Remember, you can withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

CHU Bordeaux
Verified postcode
Bordeaux, France

Common questions

What is an unruptured brain aneurysm?

It's a weak spot in a blood vessel in your brain that bulges out like a small bubble but hasn't burst yet.

What is a flow diverter stent?

It's a small mesh tube placed inside a blood vessel to redirect blood flow away from the aneurysm, helping it to heal.

Why is this study being done?

Doctors want to learn more about how safe and effective the Silk Vista device is and how it performs over time, including if its shape changes.

Will I have extra doctor visits if I join the study?

Yes, you will have scheduled follow-up appointments, including scans and health checks, to monitor your condition and the device.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.

How to find out more

Omer Eker, MD, PhD

omer.eker@chu-bordeaux.fr +33 (0)5 56 79 56 79 Official trial record

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