C-GUARDIANS Data Published for InspireMD’s CGuard Prime Carotid Stent

January 16, 2026—InspireMD, Inc., developer of the CGuard Prime carotid stent system for the prevention of stroke, announced that results from the company’s C-GUARDIANS pivotal trial have been published by D. Christopher Metzger, MD, et al in Journal of the American College of Cardiology. Dr. Metzger is the lead investigator of the trial.

According to InspireMD, the C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard carotid stent system for the treatment of carotid artery stenosis (CAS). The study enrolled 316 patients across 24 trial sites in the United States and Europe. The trial included both symptomatic and asymptomatic patients undergoing CAS.

The data demonstrate the safety and efficacy of the FDA-approved CGuard Prime for CAS with the company’s MicroNet covered stent technology in patients with asymptomatic carotid stenosis, stated the company.

The press released noted that the C-GUARDIANS trials previously demonstrated low rates of disabling stroke or myocardial infarction (DSMI) through 30 days and low ipsilateral stroke rates through 1 year, with no unexpected device-related adverse events reported. The data were presented at VIVA in late 2023 and at LINC in 2024.

“The C-GUARDIANS results are exceptional, with a 30-day DSMI rate of just 0.95% and a 1-year ipsilateral stroke rate of 1.93%, which are the lowest reported in high-risk patients,” commented Dr. Metzger in the company’s press release. “What’s particularly noteworthy is that we achieved these outcomes in a cohort that included 25% symptomatic patients, a group traditionally at elevated risk. The data make a compelling case for the CGuard Prime’s MicroNet technology as a potential next-generation standard of care.”