Study to Evaluate Success of the CGuard Prime Carotid Stent System with ENROUTE Neuroprotection in High-Risk Patients Undergoing Carotid Artery Stenting via Transcarotid Artery Revascularization

What this Trial Is About

The trial investigates the use of the CGuard Prime Carotid Stent System combined with the ENROUTE Transcarotid Neuroprotection System during Transcarotid Artery Revascularization procedures. It focuses on patients with carotid artery stenosis who are at high risk for problems from carotid endarterectomy. The study is a prospective, multi-center, single-arm pivotal trial aiming to evaluate the acute device and technical success of this device combination. Participants will undergo the Transcarotid Artery Revascularization procedure using the CGuard Prime 80cm stent system alongside the FDA-cleared ENROUTE Neuroprotection System. The study will enroll a minimum of 50 pivotal patients, with an additional roll-in cohort possible. Patients are screened for eligibility before enrollment, and the study is not blinded. The procedure is done once, and follow-up assessments extend up to one year. During the study, participants will be monitored from enrollment through follow-up visits for up to one year. Researchers will assess acute device success and technical success, along with secondary outcomes such as procedural and treatment success, rates of death, stroke, myocardial infarction, stent thrombosis, and serious adverse events within 30 days and up to one year. The study emphasizes safety and effectiveness monitoring through regular follow-ups to evaluate these outcomes.

A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach