Compares a carotid stent with medical care alone in neck artery disease
Studies a carotid stent versus medicines alone in adults with symptomatic non-stenotic carotid disease.
Plain-language title generated from the registry record
Registry title: High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Key facts
- Where
- Solingen, GermanySee the site
Where in Germany
- Städtisches Klinikum SolingenSolingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Acandis GmbH
- Trial code
- NCT07166731
- Record updated
- 4 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Patients with blood coagulation disorders; 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 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; 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 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 not able to visit the outpatient clinic for annual follow-up.