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 acute complete occlusion of the carotid artery in an emergency setting
Incidence of acute infarcts in other vascular (i.e., not ipsilateral carotid) territories
Small vessel disease
Large vessel atherosclerotic disease ≥ 50%
Patients with \<50% symptomatic non-stenotic carotid disease (SyNC) who were treated after randomisation by: Endovascular Treatment Group: Stenting + medical management o This group will be both given medical treatment according to standard clinical routine and treated by carotid artery stenting with the high coverage carotid stent (CARESTO® heal, Acandis® Pforzheim) Best medical treatment group: Medical management alone o This group will be given medical treatment according to standard clinical routine
Other
Prospective
Not listed
Primary Endpoint as rate of events of ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia analysed as time to first occurence
Ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up analysed as time to first occurence
Secondary Endpoint of Incidence of events and change from functional status
* Each of the components of the primary outcome: Rate of Ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia * A composite of rate of ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up or any symptomatic stroke, death, or myocardial infarction within 30 ± 10 days after randomisation * A composite of rate of disabling ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up or disabling stroke, death, or disabling myocardial infarction within 30 ± 10 days after randomisation, where disabling is defined as any event resulting in a worsening by at least one point on the modified Rankin Scale (mRS) (e.g. 0-6) * Rate of any change in functional status from admission to follow-up visits, assessed using the Canadian Outcome Scale for MinOr Stroke (COSMOS), comparing post-stroke functioning at follow-up to the patient's functional status recorded at hospital admission (e.g. 0-6)
Secondary Endpoint of Incidence of events and change from functional status
* Occurrence of stroke between randomisation and treatment initiation for both groups * Occurrence of further complications during follow-up: * Rate of any stroke (ischemic or haemorrhagic) as time to the first occurrence * Rate of death (any) as time to event endpoint * Rate of transient ischemic attack (TIA) as time to the first occurrence * Rate of ipsilateral transient ocular symptoms, e.g., Amaurosis fugax, as time to the first occurrence * Rate pf myocardial infarction as time to the first occurrence * Rate of device- and procedure-related (S)AEs * Rate of plaque progression or re-stenosis requiring (further) treatment (e.g., carotid artery stenting, carotid endarterectomy) * Change in the modified Rankin Scale (mRS) score at 30±10 days and during annual status checks at 12-72 months, as compared to mRS pre-randomisation (Delta mRS) (e.g. mRS 0-6)
Safety Endpoint as rate of symptomatic stroke, death, or myocardial infarktion as safety endpoint
Any symptomatic stroke, death, or myocardial infarction within 30 ± 10 days after randomisation, evaluated through blinded functional assessment based on in-hospital follow-up and/or telephone interviews with statistical comparison of the endovascular treatment arm to a performance goal derived from the best available evidence in previous stenting studies
Treatment Endpoints as rate of (Peri-)procedural complications
•(Peri-)procedural complications related to endovascular treatment, assessed up to in-hospital follow-up/discharge and based on clinical routine measurements * Examination of functional status (mRS - e.g. 0-6) and neurological status (NIHSS e.g. Number) * Symptomatic intracranial haemorrhage (SICH) defined as any intracranial haemorrhage causing any clinical deterioration and/or SICH as defined in SITS-MOST: Local or remote parenchymal hematoma type 2 on the imaging scan, plus neurological deterioration, as indicated by a score on the NIHSS ≥ 4 points, or leading to death * Lumen narrowing post-stent placement per NASCET criteria (%) * Major bleeding defined as occurring when at least one of the following conditions is met: * Fatal bleeding * Symptomatic bleeding in a critical organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular bleeding associated with compartment syndrome. * A hemoglobin drop of ≥2 g/dL.
Exploratory outcomes as rate of morphological changes
•Rate of morphological changes observed in high-risk plaques due to their progression and potential implications for patient management strategies at annual follow-up related to ultrasound examination
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