Enrollment Complete in CathWorks’ FFRangio System Study

CathWorks has finished enrolling patients in a trial that will assess its coronary artery disease (CAD) diagnosis and treatment technology.

The Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE) randomized controlled trial will evaluate the clinical and economic benefits of the CathWorks FFRangio System, offering evidence that may redefine the standard of care.

The ALL-RISE Study included more than 1,924 patients across 59 sites in North America, Asia, Europe, and the Middle East. Participants with significant intermediate coronary stenoses symptoms, needing physiology assessment were randomized to receive either FFRangio-guided treatment or invasive pressure wire-guided treatment. Notably, this was the first-ever randomized controlled trial in the United States to assess clinical outcomes using an angiography-based tool for physiologic lesion assessment.

“On behalf of the study executive committee, we would like to congratulate and thank all the global investigators, study coordinators and patients who collectively enabled this incredible accomplishment,” ALL-RISE study chair Dr. Ajay J. Kirtane (NewYork-Presbyterian/Columbia University Irving Medical Center) and principal investigators, Dr. William Fearon (Stanford University) and Dr. Allen Jeremias (St. Francis Hospital & Heart Center), said in a joint statement. “The high level of engagement and record speed of enrollment parallel the growing adoption of FFRangio globally. We look forward to sharing the results of this landmark study after clinical follow-up is completed.”    

Cardiovascular disease (CVD) remains the leading cause of death in the United States. According to the American Heart Association’s (AHA) 2024 Heart Disease and Stroke Statistics Update, CVD accounted for 931,578 deaths in the U.S. in 2021, and close to 18 million deaths globally. CAD is the single largest contributor, responsible for more than 40% of CV deaths. CathWorks is confident the ALL-RISE study results will build on what the company refers to as a new era in physiology, underscoring FFRangio as the new standard of care with the potential to drive better patient outcomes while delivering tangible economic and resource utilization benefits to healthcare systems.

“The completion of ALL-RISE enrollment marks a significant milestone for our company and team’s mission to transform how cardiovascular disease is diagnosed and treated,” CathWorks Senior Director of Clinical Affairs Alex Froimovich M.D., stated. “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.”

CathWorks’ FFRangio System combines artificial intelligence and advanced computational science, transforming the way in which cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree.