Cydar Medical and King’s College London initiate randomised controlled trial of Cydar EV Maps

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Cydar Medical, in partnership with King’s College London, has initiated the ARIA study—a randomised 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) is an alternative to open aortic surgery due to perceived advantages in patient survival, reduced post-operative complications and shorter hospital lengths of stay.1   Despite these potential advantages, there is still significant variability in preoperative planning and sizing, problems associated with imprecise visualisation and device positioning intraoperatively, and inconsistent patient outcomes, a Cydar Medical press release states.

Rachel Clough, principal investigator of the ARIA study and clinical senior lecturer at King’s College London, said: “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 NHS.”

The randomised trial will enrol 340 patients in 10 sites across the UK with a clinical diagnosis of abdominal aortic or thoracoabdominal aortic aneurysm suitable for endovascular treatment.  The trial will follow patients for one year and assess the effect of Cydar EV Maps 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. “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,” added Dr Simon Neequaye, Principal Investigator at the Liverpool University Hospital NHS Foundation Trust.

Cydar EV Maps is currently available in the EU, UK and US. It is certified software-as-a-medical device with an EU CE mark and US Food and Drug Administration 510(k) clearance.

References:

  1. Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004;364(9437):843-8.

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