InspireMD recently presented 30-day results from the C-GUARDIANS US investigational device exemption (IDE) clinical trial evaluating its CGuard embolic prevention stent (EPS) system for stroke prevention at the annual Vascular Interventional Advances (VIVA) meeting (30 October–2 November 2023, Las Vegas, USA). The presentation, which was accepted as a late-breaking abstract, was delivered by Chris Metzger (OhioHealth, Columbus, USA), principal investigator of the C-GUARDIANS trial.
C-GUARDIANS is a pivotal trial designed to evaluate the safety and efficacy of the CGuard carotid stent system when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting (CAS) and at a high risk for carotid endarterectomy (CEA).
From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study, performed at 24 sites in the USA and Europe. The primary endpoint was a composite of either: incidence of major adverse events including death (all-cause mortality), any stroke or myocardial infarction (DSMI) through 30 days post-index procedure; or ipsilateral stroke from day 31 to day 365 post-procedure.
Stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for CEA had a DSMI rate of 0.95%, from procedure through 30 days of follow-up, as per an InspireMD press release.
“The follow-up data from C-GUARDIANS once again support the safety of the CGuard EPS stent, with its novel MicroNet technology, as reflected in the low rate of major adverse events observed through 30 days,” said Marvin Slosman, chief executive officer of InspireMD. “We believe the neuroprotective qualities of CGuard set it apart from competing stents on the market and should help accelerate the ongoing shift in carotid revascularisations from ‘surgery-first’ to an endovascular ‘stent-first’ approach. We look forward to reporting 12-month results as we continue to advance CGuard EPS toward potential FDA [Food and Drug Administration] approval in the first half of 2025.”
InspireMD also anticipates reporting primary endpoint results from C-GUARDIANS—which may support a premarket approval (PMA) application—in the second half of 2024.
