Cydar Medical has partnered with King’s College London to initiate the ARIA study—a randomized controlled trial to assess the clinical-, technical- and cost-effectiveness of a cloud-based, artificially intelligent image fusion system in comparison to standard treatment to guide endovascular aortic aneurysm repair.
Endovascular aneurysm repair (EVAR), an alternative to open aortic surgery due to perceived advantages in patient survival, reduced post-operative complications and shorter hospital lengths of stay, still sees significant variability in pre-operative planning and sizing, problems associated with imprecise visualization and device positioning intraoperatively, and inconsistent patient outcomes, Cydar said in a press release.
“Our central hypothesis is that digital technology—specifically cloud-computing and artificial intelligence (AI)—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 NHS,” said Rachel Clough, MD, principal investigator of the ARIA Study and clinical senior lecturer from King’s College London in London.
The randomized trial will enroll 340 patients at 10 sites across the United Kingdom with a clinical diagnosis of abdominal aortic or thoracoabdominal aortic aneurysm (AAA and TAAA, respectively) suitable for endovascular treatment. The trial will follow patients for one year and assess the effect of Cydar EV Maps—certified software-as-a-medical device—on clinical-, technical- and cost-effectiveness in comparison to standard treatment in endovascular aortic aneurysm repair, used for both standard and complex devices.
The study was initiated with the first patient enrolled at the Liverpool University Hospitals NHS Foundation Trust in Liverpool, England. “Cydar EV Maps is a game-changing technology for vascular navigation,” said Simon Neequaye, MBBS, principal investigator at the institution. “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.”
Cydar EV Maps is currently available in the EU, UK and U.S. with both European Union CE mark and Food and Drug Administration (FDA) 510(k) clearance.