CathWorks has announced the completion of enrolment for a randomised controlled trial (RCT) aimed at evaluating the FFRangio system in the diagnosis and treatment of coronary artery disease (CAD). The trial, known as Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE), has enrolled more than 1,924 subjects across 59 sites in Asia, North America, the Middle East, and Europe. This study is significant as it is the first RCT in the US to utilize an angiography-based tool for physiological lesion assessment.
Participants in the trial, who have intermediate coronary stenoses requiring physiological assessment, were randomly assigned to undergo either FFRangio-guided treatment or the traditional invasive pressure wire-guided approach. The study is chaired by Dr. Ajay Kirtane from NewYork-Presbyterian/Columbia University Irving Medical Center, with principal investigators Dr. William Fearon from Stanford University and Dr. Allen Jeremias from St Francis Hospital & Heart Center playing key roles.
Alex Froimovich, CathWorks' clinical affairs senior director, highlighted the importance of this milestone, stating, "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." He further added, "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 is designed to eliminate the need for drug stimulation and invasive pressure wires, simplifying the operator experience with an intuitive user interface enhanced by advanced AI. CathWorks believes that this system could set a new standard of care, offering significant economic and resource utilisation benefits to healthcare systems. This is particularly relevant given that cardiovascular disease remains the leading cause of death in the US, with CAD accounting for more than 40% of cardiovascular deaths.
