InspireMD’s CGuard Carotid Stent System Evaluated at 30 Days in C-GUARDIANS Pivotal Trial

November 1, 2023—C-GUARDIANS is a pivotal FDA investigational device exemption trial designed to evaluate safety and efficacy of the neuroprotective CGuard carotid stent (InspireMD, Inc.) in treating symptomatic and asymptomatic patients with carotid stenosis at a high risk for carotid endarterectomy (CEA).

From July 2021 to June 2023, 316 patients (mean age, 69.0 years; 31.6% female; 25% symptomatic) were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the United States and the European Union.

D. Christopher Metzger, MD, presented the findings during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

As summarized in the VIVA press release, procedures were performed utilizing the CGuard self-expanding stent, incorporating its patented woven Micronet mesh sleeve with small pore size of 150 µm designed to prevent plaque protrusion, utilizing approved embolic protection systems intraprocedurally.

The primary endpoint is a composite of (1) incidence of major adverse events including death (all-cause mortality), any stroke, and myocardial infarction (DSMI) through 30 days post–index procedure and (2) ipsilateral stroke from day 31 to day 365 postprocedure. All events were adjudicated by a clinical events committee. Intraprocedural cerebral protection utilized approved distal embolic filters or proximal embolic protection with flow cessation, or both.

At 30 days, total major adverse events included a cumulative DSMI of 0.95% and a cumulative stroke and death rate of 0.95% (intent to treat, 0.95%; per protocol, 0.63%). Events included an in-hospital retinal stroke and a clinically silent troponin elevation, with two additional strokes at 30 days, including a patient who did not take dual antiplatelet therapy (protocol violation).

In the C-GUARDIANS pivotal trial, stenting with the CGuard carotid stent system in patients with obstructive carotid artery disease and at high risk for CEA had an overall stroke and death rate of 0.95% from the postprocedural interval to 30-day follow-up. The results support a potential “neuroprotective” effect of the CGuard stent from the procedure to 30-day follow-up.