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.
The purpose of the CARESTAR study 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) \<50% and with high-risk plaque features for stroke recurrence compared to the medical treatment group and with respect to the mid- and long-term clinical outcomes. By randomly assigning participants to the two treatment arms, the aim is to generate bias-free and reliable data that can provide information on the optimal treatment approach in this patient group. Despite advances in medical therapy and endovascular treatment, the optimal treatment strategy for low-grade vulnerable plaques remains unclear. There is therefore an urgent need to evaluate the efficacy and safety of minimally invasive procedures such as carotid stenting against medical treatment according to clinical routine in this specific patient group. With CARESTAR, a multicentre, prospective, randomised, parallel-grouped open label and blinded safety endpoint study this gap shall be closed. Given the considerations outlined above, symptomatic non-stenotic carotid disease (SyNC) \<50% with neurological symptoms represents a desperate situation, where all available options for contribution to the improvement of the patient's state of health or to the prevention of secondary diseases should be considered.
Study Type
OBSERVATIONAL
Enrollment
536
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
Time frame: Through study completion, an average of 54 months
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)
Time frame: Through study completion, an average of 54 months
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)
Time frame: Through study completion, an average of 54 months
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