Active not recruitingNAINTERVENTIONAL

EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum VeSsel Occlusion sTroke

This study looks at treating strokes caused by a blockage in a medium-sized blood vessel in the brain. It's comparing two approaches: a special procedure called endovascular therapy (EVT) combined with the usual medical care, versus the usual medical care on its own. EVT involves gently removing the clot from the blood vessel. The main goal is to find out if adding EVT helps people recover better and have less ongoing disability in their daily lives after this type of stroke. Strokes can cause significant challenges, and researchers want to see if this additional treatment can make a real difference in people's ability to do everyday tasks three months after their stroke.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

543

Start

09 Dec 2021

Estimated completion

01 Jun 2025

Acute Ischemic Stroke

What is this study about?

This study is about a particular type of stroke called an "acute ischemic stroke." This happens when a blood clot blocks a blood vessel in the brain, stopping blood flow. While doctors already use a special clot-removing procedure called "endovascular therapy" (EVT) for strokes affecting large brain vessels, this study focuses on strokes caused by blockages in `medium-sized` vessels. These medium vessel blockages affect a good number of stroke patients every year, and doctors want to know the best way to treat them.

The study aims to compare two ways of helping people with these medium vessel strokes. One group of patients will receive the best medical care currently available, which might include medications to dissolve clots. The other group will get this same best medical care `plus` the endovascular therapy procedure. In this procedure, doctors use special tools guided through blood vessels to reach and remove the clot in the brain. The study wants to see if adding this procedure leads to a better recovery for patients.

The main thing researchers will be looking at is how well people are able to carry out their daily activities and how much disability they have three months after their stroke. This will help them understand if endovascular therapy is a safe and effective extra treatment for this specific type of stroke, potentially improving the lives of many patients.

Key takeaways

This study investigates a new approach for medium vessel stroke.
It compares clot-removing therapy plus standard care against standard care alone.
The main goal is to see if the new approach reduces long-term disability.
Participation involves close monitoring and follow-up, especially at 3 months.
There are potential benefits and risks, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to have recently had an acute ischemic stroke that doctors believe is caused by a blockage in a medium-sized brain blood vessel. This blockage must be confirmed by scans like a CT or MRI. It's important that treatment can start within 24 hours of when your stroke symptoms began or when you were last known to be well, and often much sooner.

You would also need to have certain changes visible on your brain scans that suggest the brain tissue could still be saved by restoring blood flow. Your physical symptoms from the stroke should also be noticeable enough that they are clearly causing difficulties, such as problems with speech or vision. Finally, the doctors involved would need to agree that performing the endovascular procedure is appropriate for your situation.

There are also reasons why someone might not be able to join the study. For example, if you have bleeding in your brain, are already very unwell or bedridden, are pregnant or breastfeeding, or have certain other serious health problems or allergies. If you live very far away and wouldn't be able to come for follow-up appointments, or if brain scans show a large tumour, you might also be unable 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.

Have I recently had a stroke caused by a clot?
Do doctors think my stroke is due to a blockage in a medium-sized brain blood vessel?
Can treatment start within 24 hours of my stroke symptoms beginning?
Do my brain scans show a treatable blockage and potentially salvageable brain tissue?
Are my stroke symptoms significantly affecting me, like problems with speech or movement?
Am I not pregnant or breastfeeding, and don't have other serious existing conditions that would prevent participation?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part in this study, you would first receive either the standard medical care for your stroke, or the standard medical care plus the endovascular therapy procedure. The doctors will decide which treatment you receive by chance, like flipping a coin. This helps ensure the results are fair.

Throughout the study, doctors and nurses will closely monitor your health. You will have regular check-ups and follow-up appointments, including brain scans, to see how you are recovering. The most important assessment will happen about three months (90 days) after your stroke, where doctors will evaluate your ability to perform daily activities. You might also have assessments at other times during the study. The total duration of your participation would involve the immediate stroke treatment and then follow-up appointments, mainly up to the 90-day mark, but could extend further for other assessments.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a treatment that could improve your recovery from stroke more than standard care alone, or you might be helping to improve treatment for future stroke patients. However, there are also risks associated with any medical procedure, including endovascular therapy, such as bleeding, infection, or other complications, although doctors will take every precaution. You would be fully informed about these potential risks before deciding to join. Importantly, you are free to leave the study at any time and for any reason, without it affecting your medical care.

Locations (56)

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

AZ Sint-Jan Brugge
Verified postcode
Bruges, Belgium
Hôpital Civil Marie Curie Charleroi
Verified postcode
Charleroi, Belgium
UZ Universiteit Gent
Verified postcode
Ghent, Belgium
AZ Groeninge
Verified postcode
Kortrijk, Belgium
Universitair Ziekenhuis Leuven
Verified postcode
Leuven, Belgium
Clinique CHC MontLégia
Verified postcode
Liège, Belgium
Helsinki University Hospital
Verified postcode
Helsinki, Finland
Turku University Hospital
Verified postcode
Turku, Finland
Uniklinik RHTW Aachen
Verified postcode
Aachen, Germany
Charité-Universitätsmedizin Berlin
Verified postcode
Berlin, Germany
Klinikum Bremen-Mitte
Verified postcode
Bremen, Germany
Uniklinikum Dresden
Verified postcode
Dresden, Germany

Common questions

What is 'endovascular therapy'?

It's a special procedure where doctors use tiny tools guided through your blood vessels to remove a clot that's blocking blood flow to your brain during a stroke.

What is a 'medium vessel occlusion stroke'?

This is a stroke caused by a blood clot blocking one of the medium-sized blood vessels in your brain.

Will I definitely get the special procedure if I join the study?

No, you might receive the special procedure plus standard care, or just standard care. Which one you get is decided by chance, to keep the study fair.

How long will the study follow me?

The main follow-up measuring your recovery will be about three months (90 days) after your stroke, though there may be other checks too.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect the medical care you receive.