High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)

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.