CathWorks has completed the enrolment for a randomised controlled trial (RCT), evaluating the FFRangio system in diagnosing and treating coronary artery disease (CAD).
The Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE) trial has enrolled more than 1,924 subjects across 59 sites in Asia, North America, the Middle East, and Europe. It aims to assess the system’s economic and clinical benefits.
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It is claimed to be the ‘first RCT’ in the US region to leverage an angiography-based tool for physiological lesion assessment.
Subjects in the trial, having intermediate coronary stenoses requiring physiological assessment, were randomised to undergo either FFRangio-guided treatment or the traditional invasive pressure wire-guided approach.
Dr Ajay Kirtane, the ALL-RISE Study chair from NewYork-Presbyterian/Columbia University Irving Medical Center, along with principal investigators Dr William Fearon from Stanford University; and Dr Allen Jeremias from St Francis Hospital & Heart Center, have been instrumental in this study.
CathWorks clinical affairs senior director Alex Froimovich said: “The completion of ALL-RISE enrolment marks a significant milestone for our company and team’s mission to transform how cardiovascular disease is diagnosed and treated.
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By GlobalData“We believe this study, adding to FFRangio’s growing body of clinical evidence, has the potential to significantly advance the field of coronary physiology and close the gap between its current adoption and the appropriate use guidelines recommendations.”
The FFRangio system eliminates the need for drug stimulation and invasive pressure wires, and ‘simplifies’ the operator experience with an intuitive user interface enhanced by ‘advanced’ AI.
The company noted that the system could become the new standard of care, offering significant ‘economic’ and ‘resource utilisation’ benefits to healthcare systems.
Cardiovascular disease remains the leading cause of death in the US, with CAD accounting for more than 40% of cardiovascular deaths.
