CathWorks, a leader in medical device digital health innovation, has announced the successful completion of enrollment for the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE) randomized controlled trial (RCT). This landmark study marks a pivotal step in evaluating the clinical and economic benefits of the CathWorks FFRangio® System for diagnosing and treating coronary artery disease (CAD), with findings that could potentially reshape the standard of care in interventional cardiology.
A Truly Global Effort
The ALL-RISE trial successfully enrolled over 1,924 patients at 59 sites across North America, Asia, Europe, and the Middle East. Patients presenting with intermediate coronary stenoses requiring physiological assessment were randomised to receive treatment guided by either FFRangio or invasive pressure wire-based methods. Notably, this is the first-ever randomized controlled trial conducted in the United States to evaluate clinical outcomes using an angiography-based tool for physiologic lesion assessment.
This ambitious study highlights the growing global interest in non-invasive solutions for CAD diagnosis. The FFRangio system, already demonstrating high diagnostic accuracy, provides a promising alternative to traditional methods, reducing the risks associated with invasive pressure wire procedures.
Recognising a Collaborative Achievement
The ALL-RISE trial owes its success to the dedication of an extensive network of medical professionals and patients. Dr. Ajay J. Kirtane (NewYork-Presbyterian/Columbia University Irving Medical Center), alongside Principal Investigators Dr. William Fearon (Stanford University) and Dr. Allen Jeremias (St. Francis Hospital & Heart Center), acknowledged this collective effort:
“On behalf of the study executive committee, we extend our heartfelt thanks to the global investigators, study coordinators, and patients who made this possible. The unprecedented engagement and speed of enrollment reflect the growing adoption of FFRangio worldwide. We eagerly await the study’s outcomes following clinical follow-up.”
Shaping the Future of Coronary Physiology
CathWorks’ FFRangio system leverages advanced angiography to provide detailed physiological assessments, allowing physicians to diagnose CAD with unprecedented accuracy. This technology stands apart from traditional angiography-based methods due to its ability to provide highly reliable data without requiring invasive procedures.
Alex Froimovich, M.D., Senior Director of Clinical Affairs at CathWorks, highlighted the study’s significance:
“Completing ALL-RISE enrollment represents a major milestone in our mission to revolutionise cardiovascular disease diagnosis and treatment. By contributing to FFRangio’s robust body of evidence, this study could bridge the gap between current adoption rates and guideline recommendations. FFRangio’s proven diagnostic accuracy reinforces the need for technology-specific clinical data to drive future advancements.”
Addressing a Global Health Challenge
Cardiovascular disease remains the leading cause of death worldwide, with the American Heart Association’s 2024 update reporting 931,578 fatalities in the United States in 2021 and nearly 18 million globally. CAD accounts for over 40% of cardiovascular deaths, underscoring the urgent need for innovative diagnostic and treatment approaches.
CathWorks anticipates that the ALL-RISE study results will herald a new era in coronary physiology, positioning FFRangio as a groundbreaking standard of care. Beyond improving patient outcomes, the system offers economic benefits, optimising resource utilisation within healthcare systems globally.
The findings of the ALL-RISE trial are eagerly awaited and have the potential to transform interventional cardiology practices, ultimately improving care for millions of patients worldwide.
