Pivotal trial highlights safety, effectiveness of FDA-approved carotid stent

The CGuard Prime carotid stent system developed by InspireMD is both safe and effective as a treatment option for patients with carotid lesions, according to new research published in the Journal of the American College of Cardiology (JACC).[1] The data show the lowest 30-day and one-year primary endpoint major adverse event rates of any pivotal study of carotid stenting (CAS), which led to the stent being cleared by the U.S. Food and Drug Administration (FDA) in June 2025.

The CGuard Prime device includes a net material designed to reduce micro emboli during delivery in patients with carotid stenosis. The C-GUARDIANS pivotal trial enrolled 316 patients across 24 sites in the United States and Europe. This included patients who were at high risk for carotid endarterectomy, and a quarter of whom were symptomatic. The study looked at safety and efficacy and found low rates of disabling stroke or myocardial infarction (DSMI) through 30 days, and low ipsilateral stroke rates through one year, with no unexpected device-related adverse events.

The trial showed historically low event rates in patients with obstructive carotid disease that were consided high risk for complications in carotid endarterectomy (CEA).

“The C-GUARDIANS results are exceptional, with a 30-day DSMI rate of just 0.95% and a one-year ipsilateral stroke rate of 1.93%, which are the lowest reported in high-risk patients,” Chris Metzger, MD, an interventional cardiologist and endovascular interventionalist at Ballad Health and lead investigator of the C-GUARDIANS trial, said in a statement. “What's particularly noteworthy is that we achieved these outcomes in a cohort that included 25% symptomatic patients, a group traditionally at elevated risk."

Peter A. Soukas, MD, chief medical advisor for InspireMD, said the publication marks an important step forward in the industry's shift toward a stent-system approach to carotid revascularization. Soukas, currently the director of vascular medicine and the peripheral vascular interventional laboratory at Miriam Hospital and an associate professor of medicine at Brown University, was involved in the trial and took the chief medical advisor post in November.

“Clinicians are looking for proven technologies that expand patient eligibility without compromising outcomes. The trial data offer strong clinical validation for wider use of CGuard Prime, and we expect the JACC publication to drive further physician awareness and engagement,” Soukas said in a statement.

CGuard Prime was one of three newer generation carotid stents cleared by the FDA in past year that incorporate either a fine mesh screen covering the stent or an integrated emboli protection filter to prevent the release of emboli during stent delivery. The stent is FDA indicated for preventing stroke in patients with carotid artery disease.

Carotid stenting received considerable attention after a 2023 policy update from the U.S. Centers for Medicare and Medicaid Services (CMS) that expanded coverage for percutaneous transluminal angioplasty of the carotid artery concurrent with stenting. The updated Medicare coverage increased the use of carotid artery stenting over traditional carotid endarterectomy surgery.