InspireMD today announced that it has completed enrolment of its ongoing C-Guardians US Investigational Device Exemption (IDE) clinical trial, designed to support potential US marketing approval of its CGuard Prime embolic prevention stent (EPS) system.
The C-Guardians clinical trial is evaluating the safety and efficacy of the CGuard carotid stent system for the treatment of carotid artery stenosis. The study, which commenced enrolment in July 2021, enrolled 315 patients across 25 trial sites in the USA and Europe. The trial includes both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS).
Its primary endpoint is a composite of incidence of the following major adverse events: death (all‐cause mortality), all stroke, and myocardial infarction (DSMI) through 30 days post‐index procedure; or ipsilateral stroke from 31–365 days of follow‐up, based on Clinical Events Committee (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 <0.025.
“The completion of enrolment in our IDE trial is a significant milestone and brings us one step closer to potential US approval of the CGuard Prime EPS stent system,” said Marvin Slosman, CEO of InspireMD. “Notably, the trial was fully enrolled in less than two years, including first-in-human cases treated with our next-generation CGuard Prime CAS delivery platform. We believe the rapid enrolment reflects the comfort and support of the CGuard stent system by our investigators as we work to be the only company developing comprehensive, next-generation delivery and neuroprotection platforms that achieve best implant performance, and patient outcomes, through both transfemoral and transcarotid solutions.
“Completing enrolment of the C-Guardians trial, advancing our PMA [premarket approval] submission and obtaining FDA [Food and Drug Administration] approval would allow us to launch CGuard Prime EPS commercially in the USA and catalyse market adoption. We look forward to building on our global expansion and fulfilling our mission to deliver best patient therapy for carotid disease and stroke prevention.”
According to a press release, InspireMD anticipates results from the study in the second half of 2024.