Patient enrollment is now complete in the APEX-AV trial evaluating the safety and efficacy of the AlphaVac F1885 (AngioDynamics) multipurpose mechanical aspiration system for the treatment of acute intermediate-risk pulmonary embolism (PE).
APEX-AV is a single-arm investigational device exemption (IDE) study involving 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the U.S. The primary efficacy endpoint of APEX-AV is the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of major adverse events (MAEs), including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post-index procedure.
AngioDynamics initiated the study in partnership with the Pulmonary Embolism Response Team (PERT) Consortium. It is led by co-principal investigators William Brent Keeling, MD, associate professor of surgery at the Emory University School in of Medicine in Atlanta and immediate past president of Tthe PERT Consortium, and Mona Ranade, MD, assistant professor of interventional radiology at the David Geffen School of Medicine at the University of California, Los Angeles.
“Data from the APEX-AV study expands the current body of literature on the safety and efficacy of mechanical thrombectomy and broadens the PE treatment options, particularly in this space,” said Ranade.
The AlphaVac F1885 system is cleared for the removal of thromboemboli from the venous system. APEX-AV was designed to provide safety and efficacy data for a clearance specific to PE.
