Actively Recruiting
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Led by Acandis GmbH · Updated on 2026-03-04
536
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Goal is to analyse the clinical safety and efficacy of the CARESTO® heal Stent within standard clinical routine for the treatment of patients with symptomatic non-stenotic carotid disease (SyNC) and with high-risk plaque features for stroke recurrence compared to medical treatment alone with respect to the mid- and long-term clinical outcomes.
CONDITIONS
Official 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 confirmed by DWI or CT or neurological symptoms indicating ischemia in the internal carotid artery territory after excluding microangiopathy
- Acute retinal artery ischemia confirmed by ophthalmologic examination
- No other identifiable cause of stroke after standard echocardiographic exams to exclude cardiogenic or aortogenic embolism
- Symptomatic non-stenotic carotid disease defined as one or more plaques in the ipsilateral internal carotid artery causing 10-49% narrowing
- Presence of high-risk plaque features confirmed by CTA or MRI including at least two of: plaque thickness ≥ 3mm, irregular plaque surface, ulceration, <50% plaque calcification, lipid-rich necrotic core, and/or at least one of: intraplaque hemorrhage
- Presence of carotid web characterized as shelf-like or linear, smooth filling defects
- Plaque assessment with routine imaging confirmed by an independent CoreLab
- Signed informed consent form
- Age 18 years or older
- Modified Rankin Scale (mRS) score ≤ 3 at randomization
- Dual antiplatelet therapy according to standard care 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 atherosclerotic disease ≥ 50%, cardioembolism, or other known diseases such as vasculitis
- Predominantly calcified plaques with ≥ 50% calcified components on CT angiography
- Presence of intraluminal carotid thrombus characterized by 'donut sign' on CTA
- Highly tortuous vessels (>90°) that may prevent safe stent insertion
- Post-carotid endarterectomy or post-carotid artery stenting re-stenosis
- Blood coagulation disorders
- Impossible or high-risk access to carotid lesion for endovascular treatment
- Lesions in the ostium of the common carotid artery
- Known hypersensitivity to nickel-titanium or allergy to 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
Trial Site Locations
Total: 1 location
1
Städtisches Klinikum Solingen
Solingen, North Rhine-Westphalia, Germany, 42653
Actively Recruiting
Research Team
A
Acandis GmbH
CONTACT
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
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