Recruiting

Stent placement versus medication alone for carotid artery disease

Plain-English translation of NCT07166731 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated July 2026 · How we translate trials

What is this trial?

The CARESTAR study is testing a new stent called CARESTO® heal to see if placing it in the carotid artery (the major blood vessel in your neck) can better prevent another stroke than medication alone. You would have recently had a stroke or eye artery blockage caused by a vulnerable plaque in your carotid artery—a condition where the plaque hasn't narrowed the vessel much (less than 50%) but has features that make it risky. The trial will randomly assign you to either receive the stent plus standard medications, or to take medications alone, and track your outcomes over time.

Doctors aren't sure yet which approach works best for patients like you—those with early-stage, high-risk carotid plaques. This study aims to provide clear evidence about whether this minimally invasive stent procedure can reduce your risk of another stroke better than medication alone.

Do you qualify?

You likely qualify if…

you have had an acute ischemic stroke or eye artery blockage within the last two weeks caused by symptomatic carotid artery disease
your carotid artery narrowing is less than 50% but shows high-risk plaque features (such as thickness, irregular surface, ulceration, or bleeding within the plaque)
your recent stroke was confirmed by imaging (CT or MRI) and shows no other likely cause such as heart disease or severe narrowing elsewhere
you are at least 18 years old and able to function relatively independently (modified Rankin Scale score of 3 or lower)
you are willing to take dual blood-thinning medications before treatment and have signed informed consent

You likely don't qualify if…

you have a completely blocked carotid artery or a blood clot in the carotid artery
you have severe calcification (hardening) in your carotid plaque (50% or more calcified)
you have had a stroke caused by small vessel disease, large vessel disease with more than 50% narrowing, heart problems, or other conditions like vasculitis
you have blood clotting disorders, a severe nickel-titanium allergy, or a heparin allergy
you have anatomy (very tortuous or twisted vessels) that would make safe stent placement impossible, or a life expectancy of less than 12 months

What participation looks like

You will be randomly assigned to one of two groups: one group receives the CARESTO® heal stent plus standard medications, while the other group receives only standard medications. If you are in the stent group, you will undergo a minimally invasive procedure where doctors place the stent in your carotid artery. Both groups will continue taking medication as recommended, and you will have follow-up visits to monitor your recovery and check for any new strokes or complications. The trial is designed to track your health outcomes over the medium and long term to see which approach works better at preventing another stroke.

AI-generated summary from trial data · Jul 13, 2026 · Not medical advice

Trial locations(1 site)

Germany

Städtisches Klinikum Solingen, Solingen, North Rhine-Westphalia

Stent placement versus medication alone for carotid artery disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)

Contact the research team directly

Interested in joining?