CathWorks Completes Enrollment for ALL-RISE Clinical Trial, Paving the Way for Advancements in Cardiac Diagnostics

CathWorks Celebrates Enrollment Completion for the ALL-RISE Trial

In a significant achievement for the field of interventional cardiology, CathWorks has announced the successful completion of enrollment for its landmark randomized controlled trial (RCT) known as the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE). This study aims to assess the clinical and economic advantages of the CathWorks FFRangio® System in diagnosing and treating coronary artery disease (CAD).

The ALL-RISE trial involved over 1,924 patients from 59 different sites across North America, Europe, Asia, and the Middle East. Participants who exhibited coronary stenoses of intermediate significance and required a physiology assessment were randomly assigned to receive either FFRangio-guided treatment or the traditionally invasive pressure wire-guided treatment. Notably, the ALL-RISE study stands as the first-ever RCT in the U.S. to evaluate clinical outcomes with an angiography-based tool for physiologic lesion assessment.

According to the ALL-RISE Study Chair, Dr. Ajay J. Kirtane of NewYork-Presbyterian/Columbia University, the collaboration involved countless global investigators and study coordinators, highlighting the monumental effort behind this breakthrough. The speed and engagement demonstrated during this trial's enrollment underscore the growing global acceptance of the FFRangio technology. Dr. Kirtane expressed hopes that the study's results, once finalized, will significantly impact coronary physiology practices and patient outcomes.

In comments made by CathWorks Sr. Director of Clinical Affairs, Alex Froimovich, M.D., he emphasized that the completion of enrollment represents a pivotal moment for the company as it strives to revolutionize the diagnosis and treatment of cardiovascular diseases. He believes that the ALL-RISE trial will enhance the understanding of coronary physiology and ideally close the gap between current practice and appropriate clinical guidelines. Froimovich asserted that the FFRangio system has already proven to provide superior diagnostic accuracy compared to existing angiography-based technologies, emphasizing the need for specific clinical data tailored to this innovative technology.

Cardiovascular disease (CVD) remains a grave concern, being the leading cause of death in the United States, as highlighted by the American Heart Association's statistics for 2024 reflecting 931,578 deaths in 2021 alone. CAD is recognized as the primary contributor, accounting for over 40% of cardiovascular mortality rates. CathWorks anticipates that the findings from the ALL-RISE study could usher in a new era in the field of physiological assessments, positioning the FFRangio technology as the new gold standard. This, in turn, could result in improved patient outcomes with better resource utilization and economic benefits for healthcare providers.

About CathWorks

CathWorks stands at the forefront of medical device digital health innovations, dedicated to enhancing patient care worldwide. The CathWorks FFRangio® System integrates artificial intelligence and advanced computational technologies, transforming the diagnosis and management of cardiovascular diseases. Practitioners utilize the FFRangio System to derive physiological data from standard angiograms, effectively reducing the need for drug stimulation and invasive pressure wire assessments. Through this technology, doctors are equipped to obtain fast, reliable FFRangio values for the entire coronary anatomy during procedures, significantly advancing the cardiology field.

To learn more about CathWorks and their groundbreaking research, visit their official website at www.cath.works and follow them on LinkedIn @CathWorks.