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RecruitingNAINTERVENTIONAL

Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion (ETICA)

This study is for people who have had a severe stroke because a main artery in their neck (the carotid artery) is blocked. We want to see if adding a special treatment called 'endovascular therapy' (EVT) to the usual medical care helps people recover better than just having the usual medical care on its own. EVT involves a procedure to unblock the artery. Researchers will check if patients who receive EVT plus standard care have better outcomes, like improving their daily activities, after 90 days. They will also look at how safe the treatment is and other recovery measures, such as improvements in brain function and quality of life.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Montpellier
Enrolment target
200
Start
19 Aug 2024
Estimated completion
01 Nov 2026

What is this study about?

This study is testing a treatment for severe strokes caused by a blockage in a major blood vessel in the neck, called the internal carotid artery. This type of blockage can stop blood flow to part of the brain, leading to a stroke. The study wants to find out if adding a procedure called "endovascular treatment" (EVT) to the standard medical care works better than standard medical care alone. Endovascular treatment is a procedure where doctors use special tools inserted into a blood vessel to remove the blockage or open it up.

The main goal is to see if people who receive both EVT and standard medical care can become more independent in their daily lives three months after their stroke, compared to those who only receive standard medical care. Researchers will also be looking closely at how safe the EVT procedure is, and they will compare other important aspects of recovery between the two groups. This includes things like how well people are doing overall, if their brain function improves, and their quality of life.

By comparing these two approaches, the study hopes to learn if EVT can significantly improve recovery for people who have had this specific type of severe stroke. This research is important because it could lead to better treatment options in the future.

Key takeaways

  • This study investigates a specific stroke treatment.
  • It compares a special procedure plus standard care to standard care alone.
  • The main goal is to improve recovery and independence after stroke.
  • Participants will be closely monitored for about 3 months.
  • There are potential benefits and risks, like any medical treatment.

Who may be eligible?

To join this study, you need to be at least 18 years old and have recently had a severe stroke caused by a blocked artery in your neck. Doctors will need to confirm this stroke using brain scans like CT or MRI.

Your stroke symptoms must have started within the last 23 hours, or you've had changing symptoms (like mini-strokes or worsening problems) in the last 7 days. Your doctors will also need to see certain patterns on your brain scans that suggest a specific type of brain damage and a chance for the EVT procedure to help.

You cannot join if you've had similar neck artery surgery recently (within the last month), have other serious health problems that would prevent you from recovering or attending follow-up appointments, or if you had significant disability before your stroke. Your clinical team will discuss all these points with you carefully.

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.

  1. Are you at least 18 years old?
  2. Have you recently had a severe stroke caused by a blocked neck artery?
  3. Did your stroke symptoms start very recently (within 23 hours) or have they changed in the last 7 days?
  4. Do you have a pre-stroke disability score of 2 or less (meaning you were mostly independent before the stroke)?
  5. Are you able to attend follow-up appointments?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of two groups: either you will receive the endovascular treatment (EVT) in addition to best medical care, or you will receive best medical care alone. You won't get to choose which group you are in. The EVT procedure aims to unblock the artery in your neck.

Throughout the study, doctors and nurses will closely monitor your health and recovery. This will involve several check-ups and brain scans at different times, including soon after treatment and again after 90 days. They will be looking at how well you're recovering and your overall health. Your commitment will include attending these follow-up appointments, which help the researchers understand the effects of the treatments. The total participation for direct follow-up will be around 90 days.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving an advanced treatment that might improve your recovery from stroke. However, as with any medical procedure, there are potential risks associated with the endovascular treatment, including complications like further bleeding or damage to blood vessels, which your doctor will explain in detail. There's also the chance that the treatment might not help you more than standard care alone. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac
    Verified postcode
    Montpellier, France· Recruiting

Common questions

What is 'endovascular treatment'?

It's a special procedure where doctors use tiny tools through a blood vessel to clear a blockage in your brain or neck arteries.

What does 'best medical treatment' mean?

This refers to the standard, high-quality medical care that doctors currently recommend for your type of stroke.

Will I get to choose which treatment I receive?

No, you will be assigned to a group by chance, like flipping a coin. This helps make the study fair.

How long will I be involved in the study?

You'll be closely followed for about 90 days after your stroke to see how you recover.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Caroline ARQUIZAN, Medical Doctor

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

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of Acute Endovascular Treatment in Symptomatic Is…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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