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

NCT07763769 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 277

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

MedHub AutocathFFR

MedHub AutocathFFR is a software device for the analysis of previously acquired angiography data in Digital Imaging and Communications in Medicine (DICOM) format. The AutocathFFR value is computed from standard 2D angiography images, taken from two different views, retrieved from the C-arm angiography system. The FFR value is calculated using a machine-learning and computer vision algorithm. The result is intended to support the functional evaluation of coronary artery disease.

Sponsors & Collaborators

  • Medhub Ltd.

    lead INDUSTRY

Principal Investigators

  • Hector M. Garcia-Garcia, MD · Medstar Health Research Institute

Eligibility

Min Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2026-06-29
Completion
2026-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07763769 on ClinicalTrials.gov