Randomized Study Comparing Early Neurological Outcomes of Carotid Revascularization Using CGuard MicroNet Covered Stent With Distal Versus Proximal Embolic Protection Devices

What this Trial Is About

Researchers are studying patients with atherosclerotic carotid stenosis, including both symptomatic patients with stenosis over 50% and asymptomatic patients with stenosis 80% or greater. This trial compares early neurological outcomes using two different embolic protection devices combined with the CGuard microNet covered stent. The purpose is to evaluate whether distal or proximal embolic protection device placement offers better results, expanding on previous findings that showed CGuard stent implantation had advantages over classical stents using distal protection. Participants will undergo carotid artery stenting with one of two devices the Emboshield NAV6 distal embolic protection system plus the CGuard stent, or the Mo.Ma proximal cerebral protection device plus the CGuard stent. The study groups are randomized and unblinded, and both devices aim to reduce embolic events during the stenting procedure. The trial began in November 2021 and will continue until January 2027. During the study, participants will receive neurological assessments and brain imaging to detect ischemic lesions within 24 to 48 hours after the procedure. The primary outcome is the determination of these ischemic lesions, while secondary outcomes include monitoring major adverse cardiac and cerebrovascular events during and shortly after the procedure. Participants must consent to follow-up visits and procedures as part of the trial involvement.

Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS