RecruitingOBSERVATIONAL

High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)

This study, called CARESTAR, is looking into the best way to prevent strokes in people who have a condition called 'symptomatic non-stenotic carotid disease' (SyNC). This means they've recently had stroke-like symptoms, and have some 'plaque' building up in their neck arteries (carotid arteries), but it's not severe enough to narrow the artery a lot. The plaque, however, has features that suggest it's high-risk for causing another stroke. The study compares a tiny tube called a CARESTO® heal Stent, which is put into the artery to help, against simply using medicines. Doctors want to see which approach works better and is safer over time to stop more strokes. It's important because currently, there isn't a clear best treatment for this specific group of patients, and this study hopes to find answers.

At a glance

Status

Recruiting

Sponsor

Acandis GmbH

Enrolment target

536

Start

01 Mar 2026

Estimated completion

01 Jun 2032

Carotid Artery Disease Symptomatic Carotid Artery Stenosis Carotid Artery Stenting Carotid Plaque Imaging Embolic Stroke of Undetermined Source Carotid Artery Thrombosis

What is this study about?

This research study, called CARESTAR, is for people who have recently experienced a mini-stroke or temporary blindness (acute retinal artery ischemia) linked to a problem in their carotid artery. Your carotid arteries are major blood vessels in your neck that supply blood to your brain. Sometimes, fatty deposits called 'plaque' can build up inside these arteries. In this study, we're focusing on people whose arteries aren't severely narrowed by this plaque, but the plaque itself has certain features that suggest a higher risk of causing a stroke. This condition is sometimes called 'symptomatic non-stenotic carotid disease' (SyNC).

The main goal of the CARESTAR study is to find out if placing a special device called a CARESTO® heal Stent in the carotid artery is better than just using medicines to prevent future strokes in these specific patients. The stent is a small mesh tube that helps keep the artery open. Doctors are unsure which approach is the safest and most effective for people with this type of plaque, so this study aims to provide clear answers by carefully comparing both treatments over a period of time. This will help doctors make better decisions for patients like you in the future.

To make sure the results are fair and reliable, participants will be randomly chosen to receive either the stent or standard medical treatment. This means neither you nor your doctor can choose which treatment you get, which helps avoid any bias. The study will look closely at how safe each treatment is and how well it works to prevent more strokes or related problems in the medium and long term. This is a very important study because it could help many people at risk of stroke due to this tricky type of carotid artery disease.

Key takeaways

This study compares a special stent to medication for preventing strokes.
It's for people with early-stage carotid artery disease and specific 'risky' plaque.
Participants will be randomly assigned to one of the two treatment groups.
The goal is to find the safest and most effective treatment for this specific patient group.
You will have regular check-ups and monitoring if you join.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have had a recent stroke or temporary blindness, usually within the last two weeks, that doctors believe came from a problem in your carotid artery. Importantly, the scans of your brain must show a recent stroke, or you must have had symptoms that point to a stroke in the part of the brain supplied by that artery. Your eye doctor must also confirm any recent temporary blindness.

Doctors need to be sure that your stroke or temporary blindness wasn't caused by something else, like a heart problem. You would need to have some plaque in your carotid artery that narrows it by only a small amount (between 10% and 49%), and this plaque must show certain 'high-risk features' on special scans like a CT scan or MRI. These features might include the plaque being thick, having an uneven surface, or containing certain types of material. You must also be at least 18 years old and able to understand and sign a consent form. While you can have some difficulty with daily activities after your stroke, it shouldn't be too severe.

There are also reasons why you couldn't join. For example, if your carotid artery is completely blocked in a medical emergency, or if you've recently had strokes in parts of the brain not related to your carotid artery. The doctor leading the study will review your full medical history and all your scan results to confirm if you're a good fit.

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 or temporary blindness that doctors think came from my carotid artery?
Do my scans show that the plaque in my carotid artery narrows it by only a small amount (10-49%)?
Have doctors confirmed that my plaque has 'high-risk features'?
Am I at least 18 years old?
Have I taken the anti-clotting medicines recommended by my doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: either receiving a CARESTO® heal Stent or continuing with medical treatment alone. You will have regular hospital visits for check-ups, scans (like CT or MRI), and blood tests to monitor your health and the effectiveness of the treatment. These visits will be scheduled at specific times after your treatment, including short-term and long-term follow-ups. You will also need to take specific anti-clotting medications as prescribed by your doctor before and after any stenting procedure, if you are in that group. The total length of your participation in the study, including all follow-up appointments, will depend on the study's design, but it will involve monitoring your health over several months to years to see the long-term effects of the treatment. All procedures and scheduled visits will be clearly explained to you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical attention and access to a potential new treatment (the stent) that could be more effective than current options for your specific condition, possibly reducing your risk of future strokes. However, there are risks associated with the stent procedure itself, such as bleeding, infection, or a small chance of stroke during the procedure. Medical treatments also carry their own risks and side effects. All of these will be fully explained by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Städtisches Klinikum Solingen
Verified postcode
Solingen, Germany· Recruiting

Common questions

What is 'carotid artery disease (SyNC)'?

It's when you have some plaque in the main arteries in your neck that go to your brain, and even though it's not severely blocking blood flow, this plaque has features that make it risky for causing a stroke. 'SyNC' means you've recently had symptoms like a mini-stroke.

What is a CARESTO® heal Stent?

It's a small, mesh tube that doctors can place inside your carotid artery to help keep it open. In this study, they want to see if it can help prevent future strokes in people with specific types of risky plaque.

Why is this study important if my artery isn't very narrowed?

Even if an artery isn't severely narrowed, certain features of the plaque can still make it very unstable and likely to cause a stroke. Doctors don't currently have a clear 'best' treatment for this situation, so this study is trying to find answers.

Will I get to choose which treatment I receive?

No, you'll be randomly assigned to either receive the stent or standard medical treatment. This is done to make sure the study results are fair and unbiased.

What does 'high-risk plaque features' mean?

It means the plaque has certain characteristics seen on special scans (like a CT or MRI) that doctors believe make it more likely to break off and cause a stroke, even if it's not severely blocking your artery.

How to find out more

Acandis GmbH

info@acandis.com +49 (0) 7231 - 155 00 171 Official trial record

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