ALL-RISE Compares CathWorks’ FFRangio to Invasive Pressure Wire Guidance

April 3, 2026—CathWorks announced 1-year clinical outcomes of the ALL-RISE trial.

The company stated the findings showed that physiological assessment using fractional flow reserve (FFR) with the company’s FFRangio for patients presenting with coronary stenoses of intermediate significance met noninferiority to invasive pressure wire guidance in terms of major adverse cardiac events at 1 year, with improved resource utilization and reduced procedure time benefits

According to CathWorks, FFRangio is an FDA-approved angiography-derived solution that combines artificial intelligence and advanced computational science to obtain physiologic information from routine angiograms leveraging a resistance-based approach.

Ajay J. Kirtane, MD, presented the ALL-RISE 1-year clinical outcomes at ACC.26, the American College of Cardiology’s annual scientific session. Simultaneously, the findings were published by William F. Fearon, MD, et al in The New England Journal of Medicine.

As summarized in the CathWorks press release, the trial included 1,930 patients enrolled at 59 sites in North America, Asia, Europe, and the Middle East.

In the study, patients presenting with coronary stenoses of intermediate significance were randomized to physiological assessment with CathWorks FFRangio (965 patients) or an invasive pressure wire-based approach (965 patients). Participating sites could choose whether the patients randomized to the pressure wire group were assessed with FFR—requiring drug stimulation—or with nonhyperemic pressure ratio tools.

The primary endpoint of the ALL-RISE trial was a composite of death, myocardial infarction, or unplanned clinically indicated revascularization at 1 year.

CathWorks reported that at 1 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; P_{noninferiority} = .0008).

Additionally, the company noted the following:

• 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.
• The FFRangio group, despite having a slightly higher rate of percutaneous coronary intervention, demonstrated a shorter assessment time to perform the physiology analysis as well as a shorter overall procedure duration.