Safety and Efficacy of a Novel Micro Net Carotid Stent System: Results of the C-GUARDIANS Trial.

BACKGROUND

The authors report the intention-to-treat results for the C-GUARDIANS (Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting) pivotal trial in carotid artery stenting patients considered high risk for carotid endarterectomy, treated with this novel stent and followed for 1 year.

OBJECTIVES

The authors sought to evaluate the safety and efficacy of the MicroNet-covered stent in treating patients with significant carotid stenosis at high risk of adverse events from carotid endarterectomy.

METHODS

The trial is a prospective, multicenter, single-arm trial (NCT04900844). The primary endpoint was a composite of the incidence of death, all stroke, and myocardial infarction (DSMI) through 30 days postprocedure, and ipsilateral stroke from 31 to 365 days postprocedure. Secondary endpoints included the incidence of DSMI and of each individual component through 30 days, as well as the incidence of ipsilateral strokes through 30-day and 1-year follow-up. All events were adjudicated by an independent clinical events committee.

RESULTS

Between July 2021 and June 2023, 316 patients with asymptomatic ≥80% or symptomatic ≥50% carotid lesions were treated with this novel stent at 24 sites in the United States and European Union using approved embolic protection systems. The DSMI rate through 30 days was 0.95% (3/316). DSMI at 30 days and ipsilateral stroke at 1 year was 1.93% (6/296). Target lesion revascularization through 1 year was 1.0% (3/299).

CONCLUSIONS

The C-GUARDIAN trial demonstrated low rates of DSMI through 30 days, and ipsilateral stroke through 1 year. No unexpected adverse device effects or unexpected serious adverse device effects were reported. These results demonstrate that carotid artery stenting with this novel stent is safe, effective and durable, and supports the potential neuroprotective properties of this unique micro mesh-covered stent.