InspireMD recently announced that results from the C-GUARDIANS pivotal trial have now been published in the Journal of the American College of Cardiology (JACC). The data demonstrate the safety and efficacy of carotid artery stenting (CAS) with the MicroNet-covered CGuard Prime stent in patients with asymptomatic carotid stenosis, the company notes in a press release.
As shown at Vascular Interventional Advances (VIVA) in late 2023 and the Leipzig Interventional Course (LINC) in mid-2024, C-GUARDIANS demonstrated low rates of disabling stroke or myocardial infarction (DSMI) through 30 days and low ipsilateral stroke rates through one year, with no unexpected device-related adverse events reported. This pivotal trial showed historically low event rates in patients with obstructive carotid disease at high risk for complications with carotid endarterectomy (CEA). The cohort included 25% symptomatic patients, comparing favourably with similar patients treated with all forms of carotid revascularisation in clinical trials.
“The C-GUARDIANS results are exceptional, with a 30-day DSMI rate of just 0.95% and a one-year ipsilateral stroke rate of 1.93%, which are the lowest reported in high-risk patients,” said Chris Metzger (Ballad Health, Kingsport, USA), lead investigator of the C-GUARDIANS trial. “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.”
“For interventionalists, the C-GUARDIANS publication marks an important step forward in the industry shift toward a stent-system approach to carotid revascularisation,” said Peter Soukas, chief medical advisor of InspireMD. “Clinicians are looking for proven technologies that expand patient eligibility without compromising outcomes. The trial data offer strong clinical validation for wider use of CGuard Prime, and we expect the JACC publication to drive further physician awareness and engagement.”
InspireMD advises that CGuard Prime has US Food and Drug Administration (FDA) premarket approval for the treatment of carotid artery stenosis in the USA.
