MiRus Initiates STAR Trial for Siegel Transcatheter Aortic Valve to Address Aortic Stenosis
MiRus has announced the commencement of the STAR Trial, a multicenter, randomized controlled study evaluating the Siegel 8-Fr aortic transcatheter heart valve (THV). The trial aims to assess the safety and effectiveness of the Siegel THV in patients with severe aortic stenosis, a condition where the aortic valve narrows, impeding blood flow and potentially leading to heart failure. The trial will enroll 1,025 patients across the U.S., comparing the Siegel THV to other commercially available valves. The Siegel valve, noted for its nickel-free Rhenium alloy, offers precise placement and reduced risks such as stroke and pacemaker dependency. The trial's primary endpoint is a composite of mortality, stroke, and cardiovascular hospitalization at one year.