InspireMD’s CGuard System Evaluated in C-GUARDIANS IDE Trial

May 28, 2024—InspireMD, Inc., developer of the CGuard embolic prevention stent system for the prevention of stroke, announced the presentation of 1-year outcomes from its C-GUARDIANS investigational device exemption (IDE) clinical trial of the CGuard carotid stent system for the treatment of carotid artery stenosis. The company advised that the study results will support a premarket approval application to the FDA in the second half of 2024. If approved, the United States commercial launch of the CGuard Prime carotid stent system is anticipated in the first half of 2025.

D. Christopher Metzger, MD, lead Investigator of the C-GUARDIANS trial, presented the data at LINC 2024, the Leipzig Interventional Course held May 28-31, in Leipzig, Germany.

According to InspireMD, the single-arm C-GUARDIANS study prospectively enrolled 316 patients at 24 sites in the United States and the European Union from July 2021 to June 2023. The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting.

The study’s primary endpoint is a composite of (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 postprocedure based on the Clinical Events Committee independent 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% (P < .025).

The company reported that stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a primary endpoint event rate of 1.95%, from procedure through 1-year follow-up. The presentation is available on the company’s website here.

“We are very excited that the 1-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stroke, death, myocardial infarction, and target vessel revascularization in this prospective trial of high carotid endarterectomy risk patients with obstructive carotid disease, including 25% who were symptomatic,” commented Dr. Metzger in the company’s press release. “These data confirm the potential ‘neuroprotective properties’ of this unique MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease.” Dr. Metzger is System Vascular Chief at OhioHealth in Columbus, Ohio.