CathWorks Completes Enrollment in the ALL-RISE Study
CathWorks, recognized as a pioneer in digital health innovations focusing on medical devices, has made headlines by announcing that enrollment for its groundbreaking randomized controlled trial, known as the ALL-RISE trial, has been successfully completed. This trial evaluates the clinical and economic benefits of the CathWorks FFRangio® System for diagnosing and treating coronary artery disease (CAD).
The ALL-RISE trial involved an impressive total of
1,924 patients, recruited from
59 sites across
North America, Asia, Europe, and the
Middle East. Importantly, this represents the first-ever randomized controlled trial in the United States to assess clinical outcomes utilizing an angiography-based tool for physiologic lesion assessment.
Significance of the Study
As cardiovascular disease (CVD) continues to be the leading cause of death, with over
931,578 deaths reported in the U.S. in 2021 alone, this trial aims to enhance treatment protocols for coronary artery disease, which contributes to over
40% of these fatalities. The study compares the outcomes of FFRangio-guided treatment versus the traditional invasive pressure wire-guided treatment in patients with intermediate coronary stenoses requiring physiologic evaluation.
Scientific leaders behind this trial include Dr. Ajay J. Kirtane (NewYork-Presbyterian/Columbia University Irving Medical Center) along with Dr. William Fearon (Stanford University) and Dr. Allen Jeremias (St. Francis Hospital Heart Center). They expressed their appreciation for the global investigators, coordinators, and patients whose collective efforts made this milestone possible. They emphasized the swift enrollment process, which reflects the increasing acceptance of the FFRangio technology in cardiac care worldwide.
The Power of FFRangio
Dr. Alex Froimovich, the Sr. Director of Clinical Affairs at CathWorks, indicated that completing the enrollment for the ALL-RISE trial marks a pivotal achievement for the firm. The development of this study aims to transform cardiovascular diagnostics and treatments. So far, the FFRangio technology has demonstrated superior accuracy compared to existing angiography-based methods, emphasizing the importance of technology-specific clinical data in assessing treatment options.
CathWorks believes that the findings from the ALL-RISE trial will not only underscore the FFRangio® System’s efficacy but will also push cardiovascular physiology to a new frontier. Successful results could lead to a significant shift in how coronary artery disease is treated, thus potentially impacting patient outcomes and easing the burden on healthcare systems.
Looking Ahead
CathWorks anticipates that the data resulting from the ALL-RISE study will validate their vision of a paradigm shift towards better cardiovascular care standards. With cardiovascular disease projected to remain at the forefront of health challenges globally, advancements like those represented by the ALL-RISE trial could mark the beginning of a new era in patient care. As clinical follow-ups progress, the global health community eagerly awaits the trial results that may redefine treatment strategies for CAD.
About CathWorks
CathWorks is committed to innovating digital health technologies that enhance patient outcomes worldwide. The
FFRangio® System harnesses advanced AI and computational methodologies to derive physiologic data from standard angiograms. This system eliminates the need for invasive pressure wires and pharmacological stress tests, thereby streamlining the diagnostic process in interventional cardiology. For more information, please visit their website at www.cath.works or follow them on LinkedIn.