Landmark ALL-RISE® Trial Results Presented at ACC.26: CathWorks FFRangio Demonstrates Similar Clinical Outcomes to Invasive Wire-based Physiology Assessment

Late-Breaking Clinical Trial Shows Angiography-derived CathWorks FFRangio Improves Resource Utilization and Reduces Procedure Time

ALL-RISE One-year Results Simultaneously Published in the New England Journal of Medicine 

NEW ORLEANS, March 29, 2026 /PRNewswire/ -- Today at the American College of Cardiology's Annual Scientific Session (ACC.26) taking place in New Orleans, Louisiana, Dr. Ajay J. Kirtane from New York-Presbyterian/Columbia University Irving Medical Center, on behalf of the ALL-RISE Trial investigators, presented the one-year clinical outcomes of the ALL-RISE Trial that were simultaneously published in the New England Journal of Medicine. The study demonstrated that CathWorks FFRangio met non-inferiority to invasive pressure wire guidance in terms of major adverse cardiac events (MACE) at one year, with improved resource utilization and reduced procedure time benefits. 

The ALL-RISE Trial included 1930 patients enrolled across 59 global sites in North America, Asia, Europe and the Middle East. Patients presenting with coronary stenoses of intermediate significance were randomized to physiological assessment with CathWorks FFRangio (FFRangio group; 965 patients) or an invasive pressure wire-based approach (pressure wire group; 965 patients). Participating sites could choose whether the patients randomized to the pressure wire group were assessed with fractional flow reserve (FFR), requiring drug stimulation, or non-hyperemic pressure ratio (NHPR) tools. Notably, this was the first-ever randomized controlled trial in the United States to assess clinical outcomes of an FDA approved angiography-derived physiology (ADP) solution for physiologic lesion assessment and the first-ever to compare an ADP technology to either FFR or NHPR.

The primary endpoint of the ALL-RISE Trial was a composite of death, myocardial infarction or unplanned, clinically indicated revascularization at one year. At one year, the primary endpoint event rate was 6.9% for the FFRangio group and 7.1% for the pressure wire group (HR 0.98; 95% CI 0.70 to 1.39) with a non-inferiority p-value of 0.0008. Both the FFRangio group and the pressure wire group showed a similar safety profile with no apparent differences with respect to the incidence of bleeding, acute kidney injury or procedure-related adverse events.

The FFRangio group demonstrated improved resource utilization in the catheterization lab with reduced radiation exposure and less use of contrast medium than the pressure wire group. Despite having a slightly higher rate of percutaneous coronary intervention, the FFRangio group demonstrated a shorter assessment time to perform the physiology analysis as well as a shorter overall procedure duration.

In a joint statement, the Executive Study Chair, Dr. Martin B. Leon (New York-Presbyterian/Columbia University Irving Medical Center), the Study Chair and Global Principal Investigator, Dr. Ajay J. Kirtane, and Co-Principal Investigators, Dr. William Fearon (Stanford University) and Dr. Allen Jeremias (St. Francis Hospital & Heart Center), stated, "Progress in cardiovascular disease is driven by strong partnership, relentless discovery and clinical rigor that challenges existing practices. The ALL-RISE Trial is a landmark, randomized controlled trial assessing how artificial intelligence and advanced computational science can obtain physiologic information once only obtained by an invasive procedure. The compelling results of the ALL-RISE Trial demonstrating CathWorks FFRangio had similar clinical outcomes to the current reference standard should serve as the impetus to increase adoption of physiology worldwide. With significant workflow advantages and a suite of intraprocedural tools that help optimize clinical decision making, CathWorks FFRangio can help advance cardiovascular care for clinicians and patients."

The CathWorks FFRangio^® System is a unique ADP technology that combines artificial intelligence and advanced computational science to obtain physiologic information from routine angiograms leveraging a resistance-based approach. CathWorks FFRangio is the only technology that provides physiology values across the entire coronary tree to streamline assessment in multi-vessel disease. CathWorks' technology offers a virtual pullback curve and a Lesion Impact tool that enables assessing residual ischemia in tandem lesion cases. The integrated sizing tool, which has been validated against intravascular ultrasound, provides non-invasive lesion measurements to support PCI planning.

"We are grateful to the investigators, study coordinators and patients whose commitment to advancing science made the ALL-RISE Trial possible. The positive results from this landmark study add to an already robust body of clinical evidence generated from thousands of patients treated globally according to FFRangio guidance, reinforcing the distinct advantages that CathWorks FFRangio offers compared with invasive pressure wires and other ADP approaches. The ALL-RISE results mark a new dawn in coronary physiology and pave the way for CathWorks FFRangio to become the new standard of care for improving patient outcomes," said Ramin Mousavi, President & CEO of CathWorks.

"Through our strategic partnership with CathWorks, we have seen the excitement and global adoption of CathWorks FFRangio as an innovative solution that modernizes the cath lab and delivers enhanced information for decision making," said Jason Weidman, Senior Vice President and President of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. "The ALL-RISE data affirm our confidence in FFRangio's transformative impact on the diagnosis and treatment of coronary artery disease. We are excited for the future with CathWorks and believe FFRangio is poised to become a new standard worldwide."

Access the New England Journal of Medicine manuscript: https://www.nejm.org/doi/full/10.1056/NEJMoa2600949?utm_source=conf&utm_medium=qr&utm_campaign=ACC2026

ABOUT CATHWORKS

CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio^® System combines artificial intelligence and advanced computational science, transforming how 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. For more information on CathWorks, visit www.cath.works and follow @CathWorks on LinkedIn.

Investors:
Mike Feher
mike.feher@cath.works

Media:
Sarita Monico
sarita.monico@cath.works

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