InspireMD Shows Positive Data at VIVA with CGuard Carotid Stent System Demonstrating Low Rate of DSMI at 30 Days Compared to Previous Studies
11-6-23 (by: Scott Gleason) InspireMD has released 30-day follow-up results from the C-GUARDIANS clinical trial supporting the development of its CGuard embolic prevention stent (EPS) system for stroke prevention. The trial’s findings were presented at the annual Vascular Interventional Advances (VIVA) meeting held in Las Vegas, USA. The C-GUARDIANS trial, designed as a pivotal clinical investigation for FDA approval, focuses on evaluating the safety and efficacy of the CGuard carotid stent system. This stent system is utilized in the treatment of both symptomatic and asymptomatic carotid artery stenosis among patients who are at high risk for carotid endarterectomy (CEA).
Over the course of the study, spanning from July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm trial, conducted across 24 medical sites in the United States and Europe. The primary endpoint of the trial was a composite of major adverse events, including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) occurring within 30 days following the procedure. Additionally, the endpoint encompassed any ipsilateral stroke from day 31 to day 365 after the procedure. The study showed that patients at high risk for CEA who received stenting with the CGuard carotid stent system exhibited a low DSMI rate of 0.95% during the 30-day follow-up period.
Previous data sets have shown 30 day DSMI rates in the 2-6% range for carotid stenting and non-inferiority to surgical endarterectomy. However, it can be difficult to compare results across clinical studies. Competitors in the space include large cardiovascular companies such as Abbott, Cordis, Medtronic, and Boston Scientific.
Marvin Slosman, Chief Executive Officer of InspireMD, expressed confidence in the CGuard EPS stent’s neuroprotective properties. The innovative MicroNet technology, which characterizes this stent, appears to differentiate it from other stents available in the market. These positive results suggest that the CGuard EPS stent may facilitate a transition in the field of carotid revascularizations. The shift is anticipated to move away from a “surgery-first” approach to an endovascular “stent-first” method, offering physicians and patients a safer and more effective alternative.
The company is preparing to report the primary endpoint results from the C-GUARDIANS trial in the second half of 2024. If the results are positive, the company would seek to file a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) in the first half of 2025.