The prospective, multicenter, multi-national, single-arm trial evaluates the AlphaVac F18 multipurpose mechanical aspiration system. It looks at the efficacy, safety and long-term functional outcomes of using it to perform percutaneous mechanical aspiration thrombectomy.
RECOVER-AV aims to evaluate the system in acute, intermediate-risk PE to support its adoption in the European market. AlphaVac F18 received CE mark approval in May of this year, just over a month after it picked up FDA approval.
The trial follows an FDA investigational device exemption study that enrolled 122 patients across 25 U.S. sites. RECOVER-AV will take place across 20 sites in Europe with a primary efficacy endpoint of reducing right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure. Its safety endpoint focuses on the incidence of Major Adverse Events (MAEs). Those include device-related death or major bleeding within seven days.
AngioDynamics said investigators plan to follow patients for 12 months. They will assess functional outcomes at 30 days, six months and 12 months.
AlphaVac F18, an emergent first-line device, offers non-surgical removal of thromboemboli from pulmonary arteries in addition to treating PE. It features an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator and a waste bag assembly.
“With our clinical partners, we are demonstrating our continued commitment to generating robust clinical evidence across the world, with this being the first international study we have sponsored highlighting our commitment as a global leader to treat more patients and advance care,” said Laura Piccinini, AngioDynamics SVP and GM of Endovascular Therapies and International.
