Comparing CARESTO Heal Stent and Medical Treatment for Symptomatic Non-Stenotic Carotid Disease Evaluating Safety and Effectiveness to Prevent Stroke and Related Events

What this Trial Is About

Researchers are evaluating the clinical safety and effectiveness of the CARESTO heal Stent compared to medical treatment alone for patients with symptomatic non-stenotic carotid disease SyNC who have high-risk plaque features that increase the chance of stroke recurrence. This study aims to address the current uncertainty about the best treatment approach for low-grade vulnerable plaques by generating unbiased data through a randomized comparison of stenting versus medical therapy. The study focuses on mid- and long-term clinical outcomes in this specific patient group. Participants are randomly assigned to one of two groups one group receives medical treatment according to standard clinical care plus carotid artery stenting with the CARESTO heal stent, while the other group receives only medical treatment. This multicenter, prospective, randomized, parallel-group study follows patients in routine clinical settings to compare these two approaches. The study design includes an open-label approach with blinded safety endpoint evaluation. During the study, participants will be monitored over an average period of 54 months. Researchers will track important outcomes including the rate and timing of ipsilateral recurrent ischemic stroke or retinal artery ischemia, as well as changes in functional status. Regular follow-ups will include clinical assessments and imaging to evaluate carotid plaque features. The study also focuses on safety monitoring and the long-term effectiveness of the treatments to guide future care for patients with SyNC.

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