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)
Primary Endpoint as rate of events of ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia analysed as time to first occurence — Through study completion, an average of 54 months Ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up analysed as time to first occurence
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.
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