Actively Recruiting
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From Symptomatic Non-stenotic CARotid Disease (SyNC) - CARESTAR
Led by Acandis GmbH · Updated on 2026-03-04
536
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical safety and effectiveness of the CARESTO® heal Stent compared to medical treatment alone for patients with symptomatic non-stenotic carotid disease (SyNC) who have high-risk plaque features that increase the chance of stroke recurrence. This study aims to address the current uncertainty about the best treatment approach for low-grade vulnerable plaques by generating unbiased data through a randomized comparison of stenting versus medical therapy. The study focuses on mid- and long-term clinical outcomes in this specific patient group. Participants are randomly assigned to one of two groups: one group receives medical treatment according to standard clinical care plus carotid artery stenting with the CARESTO® heal stent, while the other group receives only medical treatment. This multicenter, prospective, randomized, parallel-group study follows patients in routine clinical settings to compare these two approaches. The study design includes an open-label approach with blinded safety endpoint evaluation. During the study, participants will be monitored over an average period of 54 months. Researchers will track important outcomes including the rate and timing of ipsilateral recurrent ischemic stroke or retinal artery ischemia, as well as changes in functional status. Regular follow-ups will include clinical assessments and imaging to evaluate carotid plaque features. The study also focuses on safety monitoring and the long-term effectiveness of the treatments to guide future care for patients with SyNC.
CONDITIONS
Brief Title
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with acute ischemic stroke or acute retinal artery ischemia within the last two weeks related to symptomatic non-stenotic carotid disease (SyNC) and high-risk carotid plaque features
- Ipsilateral acute ischemic stroke must be confirmed by imaging or neurological symptoms consistent with ischemia
- Acute retinal artery ischemia must be confirmed by ophthalmologic exam
- No other identifiable cause of stroke after standard echocardiographic evaluation
- Symptomatic non-stenotic carotid disease with 10-49% narrowing in the internal carotid artery
- Presence of high-risk plaque features confirmed by CTA or MRI
- Presence of carotid web characterized by specific imaging features
- Plaque assessment confirmed by independent CoreLab
- Signed informed consent
- Age 18 years or older
- Modified Rankin Scale score of 3 or less at randomization
- Receiving dual antiplatelet therapy before endovascular treatment
You will not qualify if you...
- Acute complete occlusion of the carotid artery in an emergency setting
- Acute infarcts in other vascular territories not related to the ipsilateral carotid
- Stroke likely caused by small vessel disease, large vessel disease ≥50%, cardioembolism, or other known diseases such as vasculitis
- Predominantly calcified plaques (≥50% calcified components on CT-Angiography)
- Presence of intraluminal carotid thrombus
- Highly tortuous vessels (>90°) preventing safe stent insertion
- Post-CEA or post-CAS restenosis
- Blood coagulation disorders
- Impossible or high-risk access to carotid lesion
- Lesions in the ostium of the common carotid artery
- Known allergy to nickel-titanium or heparin
- Conditions affecting life expectancy less than 12 months
- Conditions increasing risk of endovascular treatment
- Inability to attend outpatient clinic for annual follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing as per routine clinical care
Participants in the endovascular treatment group receive carotid artery stenting with the high coverage carotid stent (CARESTO® heal) alongside standard medical treatment. Participants in the medical treatment group receive medical management according to standard clinical routine.
Visits occur according to routine clinical care schedules
Duration - Approximately 54 months
Participants are monitored for the occurrence of ipsilateral recurrent ischemic stroke or retinal artery ischemia and changes in functional status over the long term.
Annual follow-up visits
Trial Site Locations
Total: 1 location
1
Städtisches Klinikum Solingen
Solingen, North Rhine-Westphalia, Germany, 42653
Actively Recruiting
Research Team
A
Acandis GmbH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here