RecruitingNAINTERVENTIONAL

Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter

This study is investigating a new tool, called the ANA Funnel Catheter, for treating a serious type of stroke where a large blood clot blocks a major blood vessel in the brain. This procedure, known as a mechanical thrombectomy, involves removing the clot. The ANA Funnel Catheter is designed to make it easier for doctors to use other devices to grab and remove the clot. It also helps temporarily stop blood flow during the procedure, which might make the clot removal more successful. Researchers want to find out if this new device is as safe and effective as the methods currently used. The goal is to improve the chances of a good recovery for people who have had this type of stroke.

At a glance

Status

Recruiting

Phase

Sponsor

Anaconda Biomed S.L.

Enrolment target

327

Start

09 Sep 2024

Estimated completion

01 Dec 2027

Acute Ischemic Stroke From Large Vessel Occlusion

What is this study about?

When someone has an acute ischaemic stroke, it means a blood clot has blocked a blood vessel in their brain, cutting off the blood supply. This can cause serious brain damage. Doctors sometimes perform a procedure called a 'mechanical thrombectomy' to remove the clot. This involves guiding a tiny device through blood vessels to the brain to capture and pull out the clot, restoring blood flow.

This study is testing a new device called the ANA Funnel Catheter. This catheter is designed to help doctors perform the thrombectomy procedure more effectively. Think of it like a funnel that helps guide other tools precisely to the clot. It also has a special feature to temporarily stop blood flow in the area during the procedure. This 'flow arrest' might help the doctors remove the clot more completely and reduce the risk of pieces breaking off and moving elsewhere.

The main goal of this research is to see if using the ANA Funnel Catheter is safe and whether it successfully improves the removal of blood clots compared to the standard methods currently used. If it proves to be effective, it could lead to better outcomes for patients recovering from this type of severe stroke. The study will compare it to established techniques using other approved clot-retrieving devices.

Key takeaways

The study investigates a new device for severe stroke caused by a large blood clot.
It aims to improve clot removal and patient recovery after stroke.
Patients would be randomly assigned to receive either the new device or standard treatment.
Safety and effectiveness compared to current methods are the main focus.
Your medical team will monitor your progress closely for about three months.
Informed consent is required, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would generally need to be between 22 and 85 years old and have recently experienced a new stroke that has caused noticeable symptoms. Your stroke would also need to be specifically caused by a large blood clot blocking a major blood vessel in your brain, and doctors would need to be able to start treatment within 16 hours of when your symptoms first appeared.

There are also specific requirements based on brain scans to make sure the treatment is suitable for your type of stroke. Importantly, you would need to be a candidate for a standard procedure to remove the clot, as recommended by your doctor. You or a legal representative would also need to give your informed consent to take part.

You would not be able to join the study if you've had a stroke in the past year or if your symptoms suggest you've had strokes in multiple parts of your brain. Also, if you have certain bleeding disorders or are taking blood thinners that make your blood too thin, you might not be suitable for the study.

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 22 and 85 years old?
Did your stroke symptoms start less than 16 hours ago?
Are your stroke symptoms caused by a large blood clot in a main brain artery?
Are you considered a candidate for a procedure to remove the clot?
Have you NOT had a stroke in the last year?
Do you NOT have specific bleeding conditions that would prevent this procedure?

Answer every question to see your result.

What does participation involve?

This study is designed as a comparison between the new ANA Funnel Catheter and the standard way of removing blood clots. If you participate, you would be randomly assigned to receive treatment using either the new device or the conventional approach. Both treatments aim to remove the blood clot from your brain. Doctors will assess how well the clot is removed immediately after the procedure.

Researchers will carefully monitor you for any procedure-related bleeding in the brain within the first 24 hours. You will also have follow-up assessments to check your recovery and overall health, typically three months after the procedure. The total duration of your active participation, including follow-up, would be around three months.

Potential risks and benefits

Participating in this study means you would receive treatment for your stroke, which is essential for your health. A potential benefit of using the ANA Funnel Catheter is that it might improve the success of clot removal, leading to a better recovery for some patients, although this is what the study aims to find out. As with any medical procedure, there are potential risks, including bleeding, infection, damage to blood vessels, or other complications related to stroke treatment. Researchers will closely monitor you for these. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (22)

Baptist Health Medical Center
Verified postcode
Jacksonville, United States· Recruiting
Grady Memorial Hospital, Emory
Verified postcode
Atlanta, United States· Recruiting
Advocate Health
Verified postcode
Park Ridge, United States· Recruiting
University of Iowa
Verified postcode
Iowa City, United States· Recruiting
Boston Medical Center
Verified postcode
Boston, United States· Recruiting
University of Buffalo Neurosurgery
Verified postcode
Buffalo, United States· Recruiting
Mount Sinai Hospital
Verified postcode
New York, United States· Recruiting
Oregon Health & Science University
Verified postcode
Portland, United States· Recruiting
University of Pittsburg Medical Center
Verified postcode
Pittsburgh, United States· Recruiting
Vanderbilt University Medical Center
Verified postcode
Nashville, United States· Recruiting
Aurora St. Luke's Medical Center
Verified postcode
Milwaukee, United States· Recruiting
Centre Hospitalier Universitaire de Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What kind of stroke is this study for?

This study is for a serious type of stroke called an acute ischaemic stroke, where a large blood clot blocks a major blood vessel in the brain.

What is the ANA Funnel Catheter?

It's a new medical device designed to help doctors more easily guide other tools to remove blood clots from the brain and to temporarily stop blood flow during the procedure.

Will I definitely get the new device if I join?

No, you would be randomly assigned to either receive treatment with the new device or the standard treatment method. It's like flipping a coin.

How long will I be involved in the study?

After your treatment, you would have follow-up checks, usually for about three months, to see how you are recovering.

What are the main goals of the study?

The study aims to see if the new device is safe and effective at removing blood clots, potentially leading to better recovery for stroke patients.

How to find out more

Hendrik Lambert

athena@anaconda.bio (404) 277-7280 Official trial record

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