High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From sympt
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 lon
| Condition(s) | Carotid Artery Disease, Symptomatic Carotid Artery Stenosis, Carotid Artery Stenting, Carotid Plaque Imaging, Embolic Stroke of Undetermined Source, Carotid Artery Thrombosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 d |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Acandis GmbH |
| Locations | Solingen, North Rhine-Westphalia, Germany |
| Start date | 2026-03-01 |
| NCT ID | NCT07166731 |
| Official listing | https://clinicaltrials.gov/study/NCT07166731 |