CathWorks has completed enrolment in the ALL-RISE trial which is evaluating the clinical and economic benefits of the CathWorks FFRangio System.
ALL-RISE is a randomised controlled trial (RCT) designed for assessing the FFRangio System’s efficacy in diagnosing and treating coronary artery disease (CAD).
According to CathWorks, the trial results show that the system could potentially redefine the standard of care in the interventional cardiology sector.
The ALL-RISE study involves 1,924 patients from 59 sites across North America, Asia, Europe, and the Middle East. ALL-RISE expands to Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment.
The first patient was recruited in June 2023 at Ascension St. John Hospital in Michigan.
Patients with intermediate coronary stenoses needing physiology assessment were randomised to receive either FFRangio-guided treatment or invasive pressure wire-guided treatment.
This study is also said to be the first randomised controlled trial in the US to evaluate clinical outcomes using an angiography-based tool for physiologic lesion assessment.
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.
“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.
“FFRangio has already demonstrated higher diagnostic accuracy over all other angio-based technologies, highlighting the fact that not all angio-based technologies are created equal, and therefore technology-specific clinical data are needed.”
The CathWorks FFRangio System uses artificial intelligence (AI) and advanced computational science to transform cardiovascular disease diagnosis and treatment.
By extracting physiologic data from routine angiograms, the FFRangio System is designed to eliminate the need for drug stimulation and invasive pressure wires.
The system delivers quick, reliable FFRangio values for the entire coronary tree, helping physicians make informed decisions during procedures.
The FFRangio System has already received 510(k) clearance from the US Food and Drug Administration (FDA), and certification from the European Union’s (EU) Medical Device Regulation (MDR).
CathWorks, which is a digital health innovations company, is developing the system to improve patient outcomes and offer significant economic and resource utilisation benefits to healthcare systems.
