AngioDynamics Commences APEX-AV Study to Assess AlphaVac F18⁸⁵ System in Treatment of PE

October 31, 2022—AngioDynamics, Inc. announced the enrollment of the first patient in the “Acute Pulmonary Embolism Extraction Trial With the AlphaVac System” (APEX-AV) clinical study at Jacobi Medical Center in New York, New York. AngioDynamics initiated the APEX-AV study in partnership with The PERT Consortium.

APEX-AV is evaluating the efficacy and safety of the company’s AlphaVac multipurpose mechanical aspiration (MMA) F18⁸⁵ system in the treatment of acute intermediate-risk pulmonary embolism (PE).

The company advised that the device is currently cleared for the removal of thromboemboli from the venous system. The AlphaVac MMA F18⁸⁵ system includes an ergonomic handle, an 18-F cannula with an 85º angle, an obturator, and a waste bag assembly.

The AlphaVac MMA F18⁸⁵ system, when used for treatment of PE, is an investigational device and is limited by United States law to investigational use, advised AngioDynamics.

According to the company, APEX-AV is a single-arm, investigational device exemption study enrolling patients with confirmed acute, intermediate-risk PE at up to 20 hospital-based sites in the United States.

The primary efficacy endpoint of the APEX-AV study is the reduction in right ventricle/left ventricle 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.

The study is led by Coprincipal Investigators William Brent Keeling, MD, and Mona Ranade, MD.

Dr. Keeling is Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine in Atlanta, Georgia, as well as President of The PERT Consortium.

Dr. Ranade is Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA in Los Angeles, California.

Dr. Keeling commented in the company’s press release, “I would like to congratulate Michael Grushko, MD, Prabhjot Singh, MD, and Seth Sokol, MD, at Jacobi Medical Center for enrolling the first patient in the APEX-AV study. The study is an important trial in the PE space and will significantly contribute to the growing body of evidence for the treatment of PE. We are looking forward to seeing a larger data set generated with the AlphaVac system.”

Dr. Sokol, who is a Cardiology Specialist at Jacobi Medical Center and the site’s Principal Investigator, added, “We are privileged to have the first patient enrolled in this important PE trial using the AlphaVac F18⁸⁵ system at Jacobi Medical Center. The procedure time was less than 60 minutes, and we were particularly impressed with the design, control, and navigability that the 18-F cannula provides.”

To facilitate patient enrollment for the APEX-AV study, AngioDynamics and The PERT Consortium have partnered with Viz.ai’s artificial intelligence–powered disease detection and intelligent care coordination platform. Utilizing access to hospital imaging, Viz.ai’s Viz Recruit technology identifies trial-eligible patients in real-time, allowing for around-the-clock discovery and notifications to clinical and research teams.

AngioDynamics noted that Viz Recruit may facilitate clinical trial enrollment by using artificial intelligence to identify eligible clinical trial candidates and connects the research team to the clinical care team in a secure, HIPAA-compliant environment. Viz.ai’s cloud-based technology broadens the recruitment funnel in both size and diversity by identifying existing patients at hub and spoke hospitals that are trial-eligible and screening patients as they are evaluated. This capability will allow for more efficient enrollment and streamline workflows and communication at APEX-AV study sites, stated the company.

Additionally, by using artificial intelligence to automatically identify patients during clinical evaluation, Viz Recruit may enable real-time recruitment within the health system. Viz Recruit’s ability to embed clinical research into the care continuum helps speed up enrollment rates, which could lead to more timely completion of clinical trials and a faster path to market for life-saving therapies.