InspireMD’s C-Guardians IDE Trial Completes Enrollment

August 8, 2023—InspireMD, Inc., developer of the CGuard embolic prevention stent (EPS) system for the prevention of stroke, recently announced completion of enrollment in the C-Guardians United States investigational device exemption (IDE) clinical trial, which is designed to support potential FDA marketing approval of the company’s CGuard Prime EPS system.

The C-Guardians trial is evaluating the safety and efficacy of the CGuard carotid stent system for the treatment of carotid artery stenosis. The study commenced enrollment in July 2021, enrolled 315 patients across 25 trial sites in the United States and Europe, and included first-in-human cases with the CGuard Prime EPS delivery platform. The trial includes both symptomatic and asymptomatic patients.

The primary endpoint includes the composite of the following incidence of the following major adverse events (a composite of all‐cause mortality, all stroke, and myocardial infarction through 30‐days post index procedure, based on the Clinical Events Committee [CEC] adjudication) or ipsilateral stroke from 31- to 365-day follow‐up, based on CEC adjudication.

The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is < 11.6% and the P value is < .025.

Results from the trial and a premarket approval submission are anticipated in H2 2024 with potential approval in the United States in H1 2025, the company notes.