Monitoring Safety and Effectiveness of TransCarotid Artery Stenting Compared to Carotid Endarterectomy A National Registry Study for Carotid Artery Disease Patients

What this Trial Is About

This research aims to monitor and compare the safety and effectiveness of a less-invasive surgical procedure called TransCarotid Artery Revascularization TCAR with the standard carotid endarterectomy CEA in people with carotid artery disease. TCAR is designed to reduce stroke risk by placing stents directly into the carotid artery while reversing blood flow, potentially lowering periprocedural stroke rates seen with other approaches. The study collects data from centers participating in the Society for Vascular Surgery Vascular Quality Initiative SVS VQI. The study observes patients treated with TCAR, which involves a surgical incision in the neck, blood flow reversal in the carotid artery during stent placement, and use of FDA-approved devices. It also includes patients undergoing CEA, which is the surgical removal of plaque from the carotid artery through an incision in the neck. Data is collected continuously in a national registry, including both high and standard surgical risk patients. Outcomes from TCAR are compared to those from CEA using standardized data and statistical adjustments. Participants information is entered into a secure web-based system by participating hospitals. The study tracks outcomes such as death or stroke in the treated carotid artery territory over one year, as well as stroke or death within 30 days after the procedure. Patients are analyzed separately as symptomatic or asymptomatic based on recent stroke or related symptoms. Data quality is monitored by a steering committee, and results will be published periodically to provide ongoing safety and effectiveness surveillance of TCAR devices.

SVS VQI TransCarotid Revascularization Surveillance Project