The CGuard Prime EPS stent system is used for the treatment of carotid artery stenosis. Credit: MAD.vertise/Shutterstock.com.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”