Active not recruitingOBSERVATIONAL

International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

This international study, called IMPACT, is designed to keep an eye on how well certain devices work when treating brain aneurysms. These devices, known as flow-diverting stents, are used during a procedure to fix a weakened blood vessel in the brain. The study aims to gather ongoing information about how safe and effective these Stryker Neurovascular devices are after they've been approved for use. By observing many patients, researchers hope to understand treatment options better and help doctors choose the best device for each patient. It's an important step to ensure patient safety and improve future treatments for brain aneurysms.

At a glance

Status

Active not recruiting

Sponsor

Stryker Neurovascular

Enrolment target

405

Start

21 Dec 2020

Estimated completion

01 Aug 2025

Intracranial Aneurysm

What is this study about?

Imagine a weak spot in a blood vessel in your brain that bulges out like a tiny balloon. This is called a brain aneurysm. If it bursts, it can be very serious. One way doctors treat these is through a procedure where they guide a tiny tube through your blood vessels up to your brain. This study specifically looks at a special device called a 'flow-diverting stent' that doctors can place inside the blood vessel near the aneurysm. This stent works by redirecting blood flow away from the aneurysm, helping it to heal and preventing it from bursting.

The IMPACT study isn't about testing a new device. Instead, it's an important 'post-market' study. This means the devices being used have already been approved for treating brain aneurysms. The study's main goal is to carefully watch and collect information from many patients around the world who are treated with these specific devices. Researchers want to continuously check how safe the devices are and how well they perform in everyday medical practice.

By gathering this real-world information, the study aims to give doctors a clearer picture of different treatment options. It helps them understand which devices might be most suitable for different types of brain aneurysms and patients. This ongoing gathering of information is crucial for ensuring that these treatments remain safe and effective, and it helps improve care for people with brain aneurysms in the long run.

Key takeaways

This study observes how existing treatments for brain aneurysms work in practice.
It focuses on specific devices called flow-diverting stents.
The goal is to gather more information on the safety and effectiveness of these treatments.
Data collected will help doctors make better decisions about treatment options for patients.
You would receive standard care for your aneurysm as part of your participation.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a brain aneurysm that your doctor believes can be treated with one of the devices being observed in the study. It's also important that you, or someone legally allowed to make decisions for you, understands the study and agrees to take part by signing a consent form. You'll also need to be able to attend all the scheduled check-ups and appointments that come with your treatment.

There are several reasons why you might not be able to join. For example, if you are pregnant or planning to become pregnant, or if you're already in another study involving medication or a device. If you have a condition that would make it hard for you to come to follow-up appointments, or if your aneurysm has recently burst (unless it was at least 21 days ago), you likely won't be able to participate. Also, certain types of brain aneurysms or blood vessel conditions, or if you can't safely take certain anti-clotting medicines, would mean you're not eligible.

Your doctor will carefully check all these points to see if this study is suitable for you. They will consider your specific health situation and the type of aneurysm you have.

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 18 years or older?
Do you have a brain aneurysm that your doctor thinks can be treated by this method?
Are you able to attend all planned follow-up appointments?
Are you not pregnant or planning to become so during the study?
Are you not currently part of another clinical study involving drugs or devices?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be receiving the standard treatment for your brain aneurysm using a specific type of device. The study is observational, which means doctors will simply collect information about your progress and the device's performance as part of your regular care. This will involve details about your treatment, including any other devices used. You will need to attend regular check-up appointments and examinations as advised by your medical team; these visits are part of the standard care you would receive anyway. The study will track your safety and how well the device is working over time, but the specific duration of your participation isn't mentioned.

Potential risks and benefits

The main benefit of participating is that you would be receiving treatment for your brain aneurysm using an approved, established device. The study aims to gather more information on these treatments to help improve care for patients like you in the future. As with any medical procedure, there are potential risks associated with the treatment itself; your doctor will discuss these with you in detail. There are no additional direct medical risks from simply being observed for this study. Importantly, joining the study is entirely voluntary, and you have the right to withdraw at any time without it affecting the quality of your care.

Locations (32)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Uniklinik Salzburg
Verified postcode
Salzburg, Austria
Helsinki University Hospital
Verified postcode
Helsinki, Finland
Turku University Hospital
Verified postcode
Turku, Finland
CHU Amiens
Verified postcode
Amiens, France
CHRU Besançon
Verified postcode
Besançon, France
CHU Pellegrin Bordeaux
Verified postcode
Bordeaux, France
CHU Cavale Blanche Brest
Verified postcode
Brest, France
CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France
Henri Mondor Créteil
Verified postcode
Créteil, France
CHU la Tronche Grenoble
Verified postcode
La Tronche, France
CHU Lille
Verified postcode
Lille, France
CHU Bron-Lyon
Verified postcode
Lyon, France

Common questions

What is a brain aneurysm?

A brain aneurysm is a weak, bulging spot in a blood vessel in your brain, a bit like a small balloon on the side of a garden hose.

What is a flow-diverting stent?

It's a small, mesh-like tube doctors can place inside your blood vessel to guide blood flow away from the aneurysm, helping it to heal.

Is this study testing a new treatment?

No, this study is observing already approved treatments. It aims to collect more information on how well they work and how safe they are in real-world use.

What does 'endovascular approach' mean?

It means doctors treat the aneurysm by working inside your blood vessels, usually by guiding thin tubes from a blood vessel in your leg or arm up to your brain.

Will I get paid for being in the study?

The information provided does not mention any payment for participation. Clinical studies generally focus on medical advancements rather than financial compensation.