Clinical Trial

Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)

Completed
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Summary
This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images. AutocathFFR runs on standard two-dimensional (2D) angiograms taken during cardiac catheterization. Researchers compared its results to invasive FFR, the gold standard. The main questions were: * What is the sensitivity of AutocathFFR per vessel compared to invasive FFR? * What is the specificity of AutocathFFR per vessel compared to invasive FFR? A vessel is scored "positive" when FFR ≤ 0.80 and "negative" when FFR \> 0.80. Researchers retrospectively analyzed consecutive angiograms from 4 sites in the United States. 278 patients (300 vessels) were analyzed with the AutocathFFR software, and 277 patients (297 vessels) completed AutocathFFR analysis. Participants were adults with stable angina, unstable angina, or non-ST-elevation myocardial infarction (NSTEMI) who underwent invasive coronary angiography and invasive FFR.
Trial Details
NCT Number NCT07763769
Lead Sponsor Medhub Ltd.
Conditions Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST-Elevation Myocardial Infarction
Enrollment 277 participants
Start Date 2025-11-04
Primary Completion 2026-06-29 (estimated)
Study Completion 2026-06-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-13