CathWorks Celebrates Completion of Enrollment for Groundbreaking ALL-RISE Trial in Cardiovascular Health

CathWorks' ALL-RISE Trial Enrollment Completed

CathWorks, a frontrunner in medical device innovations in digital health, has recently announced that it has successfully completed the enrollment phase for its groundbreaking randomized controlled trial, known as the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment, also referred to as the ALL-RISE study.

This pivotal trial included an impressive cohort of over 1,924 patients across 59 sites in North America, Asia, Europe, and the Middle East. The participants, all of whom presented with coronary arteries showing intermediate stenosis and requiring physiological assessment, were randomly assigned to receive treatment either guided by the FFRangio system or through traditional invasive pressure wire techniques. It is significant to note that this trial marks the first instance in the United States where an angiography-based tool for physiological lesion assessment has been used in a randomized controlled setting.

According to the statement from esteemed members of the ALL-RISE Study executive committee, including Dr. Ajay J. Kirtane from NewYork-Presbyterian/Columbia University, and Principal Investigators Dr. William Fearon of Stanford University and Dr. Allen Jeremias from St. Francis Hospital Heart Center, high levels of study engagement were a reflection of the growing acceptance and adoption of the FFRangio technology on a global scale. They have expressed gratitude to all investigators, study coordinators, and patients who contributed to this endeavor, indicating their anticipation for the upcoming results following clinical follow-up.

The completion of this enrollment phase is not only a marker of success for CathWorks but also highlights the critical advancements in how cardiovascular diseases may be diagnosed and treated. As noted by Dr. Alex Froimovich, the Senior Director of Clinical Affairs at CathWorks, the ALL-RISE study aims to bridge the existing gap between the current adoption of cardiovascular physiology technologies and the recommendations outlined in appropriate usage guidelines. The aim is to highlight the significance of technology-specific clinical data to enhance diagnostic accuracy.

Statistically, cardiovascular disease (CVD) stands as the predominant cause of death in the United States, accounting for a staggering 931,578 deaths in 2021 alone, as reported by the American Heart Association's 2024 Heart Disease and Stroke Statistics Update. Among these, over 40% are attributed to coronary artery disease, pinpointing the dire need for improved diagnostic and treatment methodologies. CathWorks is optimistic that the outcome of the ALL-RISE trial will further signify a new era in physiological assessment, potentially transforming FFRangio into the new standard of care that could enhance patient outcomes and present economic benefits for healthcare systems.

The CathWorks FFRangio System employs artificial intelligence and advanced computational techniques to revolutionize cardiovascular diagnosis and treatment. By utilizing routine angiograms, it acquires physiological data without necessitating drug stimulation or invasive procedures, delivering immediate and precise intraprocedural FFRangio values for the entire coronary system. As CathWorks continues its mission to refine cardiovascular health management, the future of heart disease diagnosis looks promising.

To learn more about the findings from the ALL-RISE study and its implications for interventional cardiology, interested parties are encouraged to follow CathWorks on LinkedIn and refer to their official website.