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Clinical Trials in Germany / NCT07166731
Recruiting Observational

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

NCT07166731 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2026-03-01
Last updated
2026-03-04

Condition(s) studied

Carotid Artery DiseaseSymptomatic Carotid Artery StenosisCarotid Artery StentingCarotid Plaque ImagingEmbolic Stroke of Undetermined SourceCarotid Artery Thrombosis

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 determined by acute ischemic infarct on DWI or CT OR * by neurological symptoms indicating ipsilateral cortical deficits consistent with ischemia in the territory of the internal carotid artery and after exclusion of a significant microangiopathy * Acute retinal artery ischemia must be determined by ophthalmologic examination * Patients with no other identifiable cause of stroke, evaluated using standard echocardiographic examinations to exclude cardiogenic or aortogenic sources of embolism * Symptomatic non-stenotic carotid disease defined as one or more plaques in the ipsilateral internal carotid artery causing 10-49% luminal narrowing AND * Presence of high-risk plaque features which must be determined through visual inspection on CTA or MRI (Ultrasound findings alone are insufficient; features must be confirmed by CTA or MRI to meet the criteria): * Identification of at least two of the following characteristics Plaque thickness ≥ 3mm Irregular plaque surface Ulceration \<50% plaque calcification Lipid-rich necrotic core * and/or identification of at least one of the following characteristics Intraplaque haemorrhage * Presence of carotid web characterized as shelf-like/linear, smooth filling defects * Plaque assessment including evaluation of the presence of high-risk features by routine imaging (CTA, MRI) confirmed by an independent CoreLab * Signed Informed Consent Form * Patient ≥ 18 years * mRS ≤ 3 at time of randomisation * Dual antiplatelet therapy (DAPT) according to standard of care before endovascular treatment Exclusion Criteria: * Patients with acute complete occlusion of the carotid artery in an emergency setting * Incidence of acute infarcts in other vascular (i.e., not ipsilateral carotid) territories * Patients in whom the stroke was likely caused by one of the following diseases: * Small vessel disease * Large vessel atherosclerotic disease ≥ 50% * Cardioembolism * Other known disease e.g. vasculitis * Predominantly calcified Plaques (≥50% calcified plaque components on CT-Angio) * Patients presenting with intraluminal carotid thrombus (e.g. characterized by 'donut sign' on CTA) * Patients with highly tortuous vessels (\>90°) which may prevent access or safe insertion of the stent * Patients with post-CEA re-stenosis or post-CAS re-stenosis * Patients with blood coagulation disorders * Patients in whom access to the carotid lesion is impossible or associated with an increased risk of procedural complications * Patients with lesions in the ostium of the common carotid artery * Patients with known hypersensitivity to nickel-titanium * Patients who are allergic to heparin * Any known conditions that affect life expectancy to less than 12 months * Any known conditions associated with an increased risk of endovascular treatment * Patients not able to visit the outpatient clinic for annual follow-up

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Städtisches Klinikum Solingen Solingen North Rhine-Westphalia Recruiting

More Acandis GmbH trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07166731 on ClinicalTrials.gov ↗ ← All trials in Germany