Cydar Medical and King’s College London Initiate ARIA Trial of Cydar EV Maps System

July 4, 2022—Cydar Medical, which is based in Cambridge, United Kingdom, announced it has initiated the ARIA study in partnership with King’s College London in the United Kingdom. The first patient in the study was enrolled at the Liverpool University Hospitals NHS Foundation Trust in Liverpool, United Kingdom.

ARIA is a randomized controlled trial to assess the clinical, technical, and cost effectiveness of the Cydar EV Maps, a cloud-based, artificially intelligent image fusion system, in comparison to standard treatment to guide endovascular aneurysm repair (EVAR).

According to Cydar Medical, the randomized trial will enroll 340 patients at 10 sites across the United Kingdom with a clinical diagnosis of abdominal aortic or thoracoabdominal aortic aneurysms suitable for endovascular treatment.

The trial will follow patients for 1 year and assess the effect of Cydar EV Maps on clinical-, technical-, and cost-effectiveness measures compared to to standard treatment in EVAR, used for both standard and complex devices.

The ARIA study’s Principal Investigator is Rachel Clough, MD, Clinical Senior Lecturer at King’s College London.

Dr. Clough commented in the Cydar Medical press release, “Our central hypothesis is that digital technology—specifically, cloud-computing and artificial intelligence—can be used to assess and learn from large volumes of data to inform clinical decision-making and has the potential to improve the predictability of individual patient outcomes and the consistency of outcomes in the National Health Service.”

Simon Neequaye, MD, who is Principal Investigator at the Liverpool University Hospital NHS Foundation Trust, added, “Cydar EV Maps is a game-changing technology for vascular navigation. The ARIA study provides a unique opportunity to demonstrate the benefits, like reduced procedure time and reduction to radiation exposure; although, some of the more subtle benefits related to procedural quality and reduced operator fatigue may never be directly measured but are obvious as an operator.”

The study was awarded funding by the National Institute for Health and Care Research under their Invention for Innovation (i4i) program.

Cydar EV Maps, which is the first product from the company’s integrated software solutions system, is currently available in the European Union, United Kingdom, and United States. It is certified Software-as-a-Medical Device with CE Mark approval and FDA 510(k) clearance, advised the company.