NCT07166731

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 536 (estimated)
• Sponsor: Acandis GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Carotid Artery Disease
• Symptomatic Carotid Artery Stenosis
• Carotid Artery Stenting
• Carotid Plaque Imaging
• Embolic Stroke of Undetermined Source
• Carotid Artery Thrombosis

Timeline

• Start date: 2026-03-01
• Primary completion: 2032-05-31
• Completion: 2032-06-01
• First posted: 2025-09-10
• Last updated: 2026-03-04

Locations

1 site across 1 country: Germany