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