ADVERTISEMENT
InspireMD Presents Positive 30-Day Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial at VIVA23
Data demonstrate a low major adverse event rate of 0.95% through 30 days post procedure
Data demonstrate a low major adverse event rate of 0.95% through 30 days post procedure
TEL AVIV, Israel and MIAMI -- InspireMD, Inc., developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, presented 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial at the Vascular InterVentional Advances (VIVA) meeting, which is being held October 30 through November 2 in Las Vegas, NV. The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System Vascular Chief at OhioHealth in Columbus, OH and 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).
Presentation Highlights:
- 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 US and the EU.
- The primary endpoint is a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.
- Stenting with the C-Guard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, from procedure through 30 days follow-up.
Marvin Slosman, chief executive officer of InspireMD, stated, “The follow-up data from C-GUARDIANS once again supports the safety of the C-Guard EPS stent, with its novel MicroNet™ technology, as reflected in the low rate of major adverse events observed through 30 days. We believe the neuroprotective qualities of C-Guard set it apart from competing stents on the market and should help accelerate the ongoing shift in carotid revascularizations 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 approval in the first half of 2025.”
InspireMD anticipates reporting primary endpoint results from C-GUARDIANS in the second half of 2024 that may support a Premarket Approval (PMA) application.
About C-GUARDIANS
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 completed enrollment in June 2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe.
The trial includes both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the incidence of the following major adverse events: death (all‐cause mortality), any stroke, or myocardial infarction (DSMI) through 30‐days post‐index procedure or ipsilateral stroke from 31‐365-day follow‐up, based on Clinical Events Committee (CEC) adjudication. The trial will be considered a success if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is less than the performance goal of 11.6%.
The company anticipates primary endpoint results from the study in H2 2024.
Find More:
The Latest Clinical & Industry News
Grand Rounds With Morton Kern, MD
