Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients
This study is looking at a new medical device, called Ceretrieve, which is designed to help patients who have had a type of stroke called an acute ischemic stroke. This happens when a blood clot blocks blood flow to the brain. The Ceretrieve device aims to remove these clots. Researchers are checking if the device is safe to use and if it effectively reopens the blocked blood vessels in the brain. They will compare its performance to other devices already used for this purpose to ensure it works just as well. Patients in the study will be followed for three months to collect information about their progress and any safety concerns.
At a glance
What is this study about?
This research study is focused on improving treatment for a very serious type of stroke called an acute ischemic stroke. This occurs when a blood clot blocks an important blood vessel in the brain, which can cause significant damage. The study is evaluating a new device, called Ceretrieve, which is designed to help remove these blood clots and restore blood flow to the brain, a process known as revascularization. The goal is to see if this new device is both safe and effective when used to treat patients within 24 hours of their stroke symptoms starting.
The researchers will be comparing the results from using the Ceretrieve device to information already known about other devices currently approved for stroke treatment. They want to make sure that the Ceretrieve device is just as good, if not better, at unblocking the blood vessels without causing new problems. The study will look closely at how well the device successfully reopens the blocked arteries and whether any serious side effects occur, especially bleeding in the brain.
Understanding how well new treatments like Ceretrieve work is very important for improving care for stroke patients. By carefully studying this device, doctors hope to make sure that more people can recover better after a stroke. This research helps advance medical knowledge and provides new options for doctors to consider when treating this potentially life-changing condition.
Key takeaways
- This study is testing a new device (Ceretrieve) for stroke caused by blood clots.
- It aims to see if the device is safe and effective at unblocking brain arteries.
- Participation involves treatment with the device within 24 hours of stroke.
- Researchers will compare its results to existing stroke treatments.
- Patients will have a 3-month follow-up after the procedure.
- The study helps develop new options for stroke care.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or over, who has recently had an acute ischemic stroke. This is a stroke caused by a blood clot, and it needs to be confirmed by imaging tests that a main blood vessel in your brain (like parts of the internal carotid, middle cerebral, basilar, or vertebral arteries) is blocked.
Crucially, you would need to be able to receive treatment within 24 hours of your stroke symptoms starting. Before your stroke, your health would have been generally good, meaning you didn't have significant disability. You also shouldn't have had a rapid, sudden improvement in your stroke symptoms before starting the study, as this would suggest the clot might have cleared on its own.
There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have a known allergy to certain medical dyes or metals like nickel or titanium. Also, if you have a bleeding disorder or a very short life expectancy for other health reasons, you wouldn't be able to take part.
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?
- Have you recently had a stroke caused by a blood clot (acute ischemic stroke)?
- Did your stroke symptoms start less than 24 hours ago?
- Was your health generally good before your stroke?
- Are you able to have a procedure to remove the clot?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you decide to take part in this study, you would first have some checks to make sure you're suitable. Once confirmed, you would receive treatment with the Ceretrieve device within 24 hours of your stroke symptoms starting. Medical staff will monitor you closely during and immediately after the procedure.
After you leave the hospital, you will need to come back for one follow-up visit at the clinic about three months after your procedure. This visit is important for the study team to check on your health and well-being, and to collect more information about how you're recovering. The total duration of your participation in the study, from receiving the treatment to your final follow-up, will be around three months.
Potential risks and benefits
Locations (1)
- Heidelberg University HospitalVerified postcodeHeidelberg, Germany· Recruiting
Common questions
What kind of stroke is this study for?
This study is for acute ischemic stroke, which is a stroke caused by a blood clot blocking blood flow to your brain.
What does the Ceretrieve device do?
The Ceretrieve device is designed to remove blood clots from blocked blood vessels in the brain to restore blood flow.
How long will I be in the study?
You will be followed for about three months after your stroke treatment.
Will I have to take any new medicines?
The study focuses on the Ceretrieve device, not new medicines. However, standard stroke medications may be given as part of your usual care.
What happens after I leave the hospital?
You'll have one follow-up visit at the clinic about three months after your procedure to check on your recovery.
How to find out more
Hilla Hilla Ben-Ezra, Ms.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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