Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
This study, called FIRST, is gathering information on a special device known as Silk Vista or Silk Vista Baby. This device is used to treat problems in blood vessels in your brain called aneurysms. An aneurysm is like a weak bulge in a blood vessel that could potentially burst and cause serious health problems. Doctors are observing patients who are already receiving this treatment as part of their usual care. The main goal is to see how safe the device is and how well it works in real-world situations for people with brain aneurysms. This study will help us understand more about this treatment option.
At a glance
What is this study about?
Imagine the blood vessels in your brain are like tiny pipes. Sometimes, a part of one of these pipes can get a weak spot and bulge out like a small balloon. This bulge is called an aneurysm. If it bursts, it can be very serious. Doctors might suggest a special treatment to fix this called a flow diverter.
This study is looking at two types of these flow diverting devices, called Silk Vista and Silk Vista Baby. These devices are like small, net-like tubes placed inside the blood vessel at the aneurysm site. They gently redirect blood flow away from the aneurysm, helping it to heal and reduce the risk of bursting. It's important to understand how well these devices work and if they are safe for patients.
The FIRST study is not actually testing a new treatment. Instead, it's carefully watching patients who are already getting treatment with the Silk Vista or Silk Vista Baby as part of their standard care. By gathering information from many patients, doctors can learn more about how these devices perform over time and ensure they are a good option for treating brain aneurysms.
Key takeaways
- The study looks at the Silk Vista/Silk Vista Baby device for brain aneurysms.
- It collects information on safety and how well these devices work.
- Your treatment will be your usual care; the study just observes.
- You must be 18 or over and having this specific treatment.
- Your participation helps improve understanding for future patients.
Who may be eligible?
You might be able to take part in this study if you have a brain aneurysm that your doctor has decided to treat with either the Silk Vista or Silk Vista Baby device. This decision about your treatment must be made by your doctor independently, before you even consider joining the study.
Also, if you've had a brain aneurysm treated before with only coils (another type of treatment) and it has started to open up again, you might also be eligible. You need to be 18 years old or older and willing to sign a consent form to show that you understand and agree to take part.
However, you won't be able to join if your doctor says the Silk Vista device isn't suitable for you based on its instructions, or if your aneurysm that has started to open up again was initially treated with a stent (a different kind of device used to hold the blood vessel open) or a stent alongside coils.
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.
- My doctor has decided I need the Silk Vista or Silk Vista Baby device.
- I am 18 years old or older.
- I have been treated for an aneurysm with coils before, and it has come back.
- My doctor says the Silk Vista device is suitable for me.
What does participation involve?
If you join this study, your involvement will be very simple. You won't have any extra appointments, tests, or receive different medication than what your doctor has already planned for you. You will receive the Silk Vista or Silk Vista Baby device as part of your normal treatment for your brain aneurysm.
The study will simply collect information from your existing medical and follow-up appointments. This means your regular check-ups with your doctor will also provide important information for the study. The study team will look at your progress from the time your treatment starts up to about 12 months afterwards, as part of your usual care. There is no extra time commitment or burden on your part.
Potential risks and benefits
Locations (29)
- Universitätsklinik für NeurologieVerified postcodeSalzburg, Austria
- CHC Saint Joseph LiègeVerified postcodeLiège, Belgium
- University Hospital Centre ZagrebVerified postcodeZagreb, Croatia
- CHU de Bordeaux - Hôpital PellegrinVerified postcodeBordeaux, France
- Hopital Cavale BlancheVerified postcodeBrest, France
- Hospices Civils de Lyon - Hôpital NeurologiqueVerified postcodeBron, France
- CHU Caen, Radiologie interventionelleVerified postcodeCaen, France
- Centre Hospitalier Universitaire Clermont FerrandVerified postcodeClermont-Ferrand, France
- Centre Hospitalier Universitaire de Grenoble AlpesVerified postcodeGrenoble, France
- Hôpital Kremlin BicêtreVerified postcodeLe Kremlin-Bicêtre, France
- Chu Dupuytren LimogesVerified postcodeLimoges, France
- Hôpital Privé ClairvalVerified postcodeMarseille, France
Common questions
What is a brain aneurysm?
It's like a weak, bulging spot on a blood vessel in your brain that could burst if left untreated.
What is a flow diverter?
It's a small mesh tube placed inside the blood vessel to redirect blood flow away from the aneurysm, helping it heal.
Will my treatment be different if I join the study?
No, you will receive the exact same care and treatment your doctor has already planned for you.
How long will I be in the study?
The study will collect information from your medical records for about 12 months after your treatment, as part of your regular follow-up.
Who is running this study?
The FIRST study is an international study involving several medical centres.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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