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InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract detailing upcoming 30-day results from its C-Guardians U.S. IDE clinical trial has been accepted for presentation as a late-breaking clinical trial at the Vascular InterVentional Advances Annual Meeting (VIVA23), which is being held October 30 through November 2 in Las Vegas.
Presentation details:
| Title: | 30-Day Results from the C-Guardians Pivotal Trial of the CGuard™ Carotid Stent System |
| Presenter: | Chris Metzger, M.D., System Chair of Clinical Research at Ballad Health System and lead investigator of the C-Guardians trial |
| Date: | Wednesday, November 1, 2023 |
| Time: | 10:45am-12:00pm PT (1:45pm-3:00pm ET) |
Marvin Slosman, chief executive officer of InspireMD, stated, "We are very pleased that an abstract detailing our 30-day follow-up data from our C-Guardians IDE trial has been accepted for presentation at this year's VIVA conference, which is among the most important gatherings of endovascular specialists each year. We believe CGuard™ EPS, with its novel MiroNet™ technology, offers next-level neuroprotection that translates into superior short- and long-term patient outcomes, something we aim to demonstrate with this important trial. We also look forward to sharing one-year data from C-Guardians in the second half of next year that, if positive, may support a Premarket Approval Application (PMA) and allow us to potentially launch the CGuard Prime EPS stent system in the U.S. in the first half of 2025."
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 25 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 following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, and myocardial infarction (DSMI) through 30‐days post‐index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke from 31‐365-day follow‐up, based on CEC adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.
The company anticipates primary endpoint results from the study in H2 2024.
About VIVA
VIVA (Vascular InterVentional Advances) is a global educational event for specialists caring for patients with vascular disease. VIVA brings together attendees and faculty specializing in vascular surgery, interventional cardiology, interventional radiology, vascular medicine, neurointervention/neurosurgery, and cardiothoracic surgery, offering a uniquely comprehensive educational experience with access to some of the best minds in endovascular care.
Posted In: NSPR
