Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
This study is investigating a new medical device called the iNstroke 4F thromboaspiration catheter. It's designed to help people who have experienced a particular kind of stroke, known as an acute ischaemic stroke, where smaller blood vessels in the brain become blocked. The main goal is to understand how safe and effective this catheter is at removing these blockages. We're looking at patients aged 18 and over who have recently had this type of stroke. By understanding more about this device, doctors hope to improve treatment options for stroke patients in the future and compare it with current standard care.
At a glance
What is this study about?
This study is looking at a new device called the iNstroke 4F thromboaspiration catheter. Think of it like a very tiny, special tube designed to go into the body and gently remove blood clots that are blocking small blood vessels in the brain. This type of blockage happens in what's called an 'acute ischaemic stroke', which is when part of the brain doesn't get enough blood because of a clot.
The main purpose of this study is to see how well and how safely this new catheter works for people who have clots in these smaller, or 'distal medium', blood vessels. Researchers want to gather more information about the device's performance in real-world settings after it has already been approved for use. This will help doctors understand if it's a good tool for treating these specific types of strokes.
Ultimately, the information gathered from this study will be used to help improve future stroke treatments. By learning more about the iNstroke 4F, doctors can decide if it's better than current treatments or other similar devices. It's all about finding the best ways to help people recover from strokes.
Key takeaways
- This study evaluates a device to remove blood clots in stroke patients.
- It focuses on specific types of clots in smaller brain vessels.
- The goal is to understand the device's safety and effectiveness.
- Participation involves receiving the treatment and follow-up checks.
- It aims to improve future stroke treatments.
Who may be eligible?
To be part of this study, you need to be at least 18 years old and have had a stroke where a smaller blood vessel in your brain got blocked recently – within the last 24 hours. Doctors will need to see this blockage clearly on a brain scan. You also need to be in generally good health before the stroke, with no major existing problems that would make the treatment unsafe or unlikely to help.
There are also reasons why you might not be able to join. For example, if your stroke was caused by a different type of blockage, or if you have certain other serious health conditions like severe allergies to dye used in scans, or specific blood problems. If you're already taking part in another medical study or have certain brain conditions, you also wouldn't be able to join.
Don't worry too much about all the details now. If you're interested and think you might fit, the study doctors will go through everything with you very carefully to see if this study is suitable and safe for you.
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 old or older?
- Did your stroke symptoms start within the last 24 hours?
- Did doctors confirm a specific small blood vessel blockage in your brain?
- Were you generally healthy before your stroke (e.g., able to do your usual activities)?
- Do you have any serious allergies to 'dye' used in medical scans?
- Are you currently taking part in another medical research study?
What does participation involve?
If you decide to take part in this study, you will receive treatment with the iNstroke 4F thromboaspiration catheter, which is a procedure to remove the blood clot causing your stroke. This will happen in the hospital. The study isn't comparing different treatments; everyone in this study will receive this specific device. Doctors and nurses will then closely monitor your health and recovery over a period of time after the procedure. This will involve regular check-ups and assessments, which might include brain scans and tests to see how well you are recovering and how the device has worked. The total duration of your participation, including all follow-up appointments, will be explained fully by the study team, but it will involve several visits over a period after your stroke. You won't be given any new or different medications specifically for the study, but you'll continue to receive any standard care or medicines your doctors normally prescribe.
Potential risks and benefits
Locations (11)
- Universitätsklinikum BonnVerified postcodeBonn, Germany· Not yet recruiting
- Universitätsklinikum Schleswig-HolsteinVerified postcodeKiel, Germany· Not yet recruiting
- Klinikum MarburgVerified postcodeMarburg, Germany· Not yet recruiting
- Klinikum NürnbergVerified postcodeNuremberg, Germany· Not yet recruiting
- Knappschaftskrankenhaus RecklinghausenVerified postcodeRecklinghausen, Germany· Recruiting
- Semmelweis University CenterVerified postcodeBudapest, Hungary· Recruiting
- Hospital Universitario Vall d'HebronVerified postcodeBarcelona, Spain· Recruiting
- Hospital Universitario 12 de OctubreVerified postcodeMadrid, Spain· Not yet recruiting
- Hospital Universitario de GetafeVerified postcodeMadrid, Spain· Not yet recruiting
- Hospital Universitario La PazVerified postcodeMadrid, Spain· Not yet recruiting
- Hospital Clínico Universitario Virgen de ArrixacaVerified postcodeMurcia, Spain· Recruiting
Common questions
What is an 'acute ischaemic stroke'?
It's a type of stroke caused by a blood clot blocking an artery that supplies blood to your brain, leading to a sudden lack of blood flow.
What does a 'thromboaspiration catheter' do?
It's a small, flexible tube doctors use to reach a blood clot in your brain and carefully suck it out.
Is this a new treatment?
The iNstroke 4F catheter has been approved for use, and this study aims to gather more information on how well and safely it works in patients with specific types of stroke.
Will I get different care if I don't join the study?
No, your decision to join or not join the study will not affect the standard medical care you receive for your stroke condition.
How long does the study last?
The study involves the procedure and a series of follow-up visits. The study team will tell you the exact time commitment, but it usually involves monitoring over several months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.