InspireMD has completed the enrolment of patients in its C-Guardians US investigational device exemption (IDE) clinical trial of the CGuard Prime EPS stent system for the treatment of carotid artery stenosis.
The ongoing study is designed to assess the efficacy and safety of CGuard and includes both symptomatic and asymptomatic patients undergoing carotid artery stenting.
It enrolled a total of 315 patients from 25 trial sites in Europe and the US.
Incidence of death, all strokes and myocardial infarction through the 30-day post‐index procedure, as measured on the Clinical Events Committee adjudication, is the primary endpoint of the study.
To meet the performance goal, the p-value should be <0.025 while the upper bound of the two-sided 95% confidence interval needs to be <11.6%.
Results from the study are anticipated in the second half of next year and the US approval of CGuard in the first half of 2025.
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InspireMD CEO Marvin Slosman said: “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.
“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 the best implant performance and patient outcomes through both transfemoral and trans carotid solutions.”