The single-arm Investigational Device Exemption APEX-AV study is intended to assess the efficacy and safety of the AlphaVac MMA F1885 System in acute intermediate-risk PE
AngioDynamics has finished patient enrolment in APEX-AV study. (Credit: valelopardo from Pixabay)
AngioDynamics has concluded the patient enrolment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study of AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for pulmonary embolism (PE) treatment.
The AlphaVac MMA F1885 System is a first-line device, currently authorised to remove thromboemboli from the venous system.
The single-arm Investigational Device Exemption (IDE) APEX-AV study is intended to assess the efficacy and safety of the system in acute intermediate-risk PE.
It will be conducted at 25 hospital-based sites in the US that enrolled 122 individuals with confirmed acute, intermediate-risk PE. The first patient was enrolled in November last year.
The primary efficacy endpoint was defined as the reduction in RV/LV ratio between baseline and 48 hours post-procedure.
The primary safety endpoint included the rate of Major Adverse Events (MAEs), including significant bleeding and device-related death during the first 48 hours.
In addition, the patients after the index procedure will be monitored for 30 days.
AngioDynamics clinical and scientific affairs senior vice president Juan Serna said: “The completion of the APEX-AV Study to assess the performance of the AlphaVac F1885 System in reducing thrombus burden and improving right ventricular function is a meaningful step toward expanding treatment options and improving care for patients with pulmonary embolism.
“We thank The PERT Consortium, including our enrolling partners, for its commitment to generating robust clinical evidence to help address the needs of this patient population.”
The trial was started in collaboration with the Pulmonary Embolism Response Team (PERT) Consortium, which aims to advance the PE care status and promote research in PE treatment.
Co-principal investigators of the study are Mona Ranade, an assistant professor of interventional radiology at UCLA’s David Geffen School of Medicine, and William Brent Keeling, an associate professor of surgery in the department of surgery at Emory University School of Medicine.
Ranade said: “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.”