The company has partnered with PERT Consortium and Viz.ai to facilitate future enrolment of patients in the APEX-AV study of the AlphaVac F1885 System
AngioDynamics enrols first patient in the APEX-AV study. (Credit: kalhh from Pixabay)
AngioDynamics has reported the first patient enrolment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) to evaluate the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of pulmonary embolism (PE).
APEX-AV is a single-arm investigational device exemption (IDE) trial to study the AlphaVac system in patients having confirmed acute, intermediate-risk PE. The study will be held at up to 20 hospital-based locations in the US.
The medical technology company said that the study’s primary efficacy endpoint is the decrease in the right ventricle/ left ventricle (RV/LV) ratio from baseline to 48 hours after the surgery. The rate of major adverse events (MAEs), such as device-related death and major bleeding during the first 48 hours after surgery, is the primary safety endpoint.
AngioDynamics clinical and scientific affairs senior vice president Juan Carlos Serna said: “We are excited to have the first patient enrolled in this important trial as we assess the performance of the AlphaVac F1885 System in patients with intermediate-risk pulmonary embolisms.
“With our partners, we are demonstrating our continued commitment to generating robust clinical evidence with the potential to support our clinical and regulatory strategy to pursue additional indications to treat more patients and advance care.”
The AlphaVac MMA F1885 System is currently cleared as a first-line device for the extraction of thromboemboli from the venous system. It consists of a handle, an 85-degree-angled 18F cannula, an obturator, and a waste bag assembly.
The firm started the trial in partnership with Pulmonary Embolism Response Team (PERT) Consortium and Viz.ai to make it easier for patients to enrol in the APEX-AV Study.
Viz.ai’s Viz RECRUIT system uses hospital imaging to access trial-eligible patients in real-time, enabling discovery and notifications to clinical and research teams.
By connecting the research team to the clinical care team and utilising artificial intelligence (AI) to find qualified clinical trial applicants, Viz RECRUIT is expected to make it easier for people to join in clinical trials.