AngioDynamics Completes Enrollment in APEX-AV Acute PE Trial

December 7, 2023—AngioDynamics, Inc. announced the completion of patient enrollment in the APEX-AV trial of acute pulmonary embolism (PE) extraction with the company’s AlphaVac multipurpose mechanical aspiration (MMA) F18⁸⁵ system.

According to the company, the APEX-AV clinical study is evaluating the safety and efficacy of the AlphaVac MMA F18⁸⁵ system in the treatment of acute, intermediate-risk PE. The system features an 18-F cannula with an 85º angle, as well as an obturator, an ergonomic handle, and a waste bag assembly.

The AlphaVac MMA F18⁸⁵ system is currently cleared for the removal of thromboemboli from the venous system. The APEX-AV study is designed to provide safety and efficacy data for a clearance specific to PE, for which it is currently an investigational device, limited by United States law to investigational use.

The single-arm investigational device exemption study enrolled 122 patients with confirmed acute, intermediate-risk PE at 25 hospital-based sites in the United States.

The primary efficacy endpoint of the study is the reduction in right ventricular–to–left ventricular ratio between baseline and 48 hours postprocedure. The primary safety endpoint is the rate of major adverse events, including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post index procedure.

AngioDynamics advised it initiated the APEX-AV study in partnership with the PERT Consortium. The commencement of enrollment was announced in October 2022.

The Coprincipal Investigators of the APEX-AV study are William Brent Keeling, MD, Immediate Past President of the PERT Consortium, and Mona Ranade, MD.

“The completion of the APEX-AV study represents an important milestone in the catheter-directed therapies space for the treatment of PE,” commented Dr. Keeling in the AngioDynamics press release. “I sincerely thank all the investigators for their commitment and dedication.”

Dr. Ranade added, “Data from the APEX-AV study expand the current body of literature on the safety and efficacy of mechanical thrombectomy and broaden the PE treatment options, particularly in this space.”

Dr. Keeling is Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine in Atlanta, Georgia. Dr. Ranade is Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA in Los Angeles, California.