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Completed

NCT Number: NCT07763769

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Non-ST-Elevation Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Unstable Angina Vascular Diseases

Age range

23 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 22 years
  • Subjects with stable angina pectoris, unstable angina pectoris, or NSTEMI and in whom invasive FFR was performed to assess a non-culprit stenosis in at least one coronary artery
  • Subject underwent a clinically indicated Invasive Coronary Angiogram (ICA)
  • Subject underwent invasive FFR with intravenous (IV) or intracoronary adenosine, or adenosine triphosphate (ATP), as hyperemic stimulus

Exclusion criteria

  • Angiogram not obtained on a United States Food and Drug Administration (FDA)-cleared C-arm angiography system
  • Invasive FFR not obtained on an FDA-cleared FFR catheter tip pressure transducer (also known as a pressure wire)
  • Vessel size less than 2 mm
  • Subject presents with an ST-elevation myocardial infarction (STEMI)
  • Chronic total occlusion (CTO) in target vessel
  • Prior coronary artery bypass graft (CABG) surgery, heart transplant or valve surgery, prior transcatheter aortic valve implantation/replacement (TAVI/TAVR), or severe left-sided valvular disease
  • Known left ventricular ejection fraction (LVEF) ≤ 30%
  • Arteries supplying akinetic or severe hypokinetic territories on target lesion, if already known based on prior imaging
  • Thrombolysis in Myocardial Infarction (TIMI) flow grade equal to or lower than 2 at baseline
  • Target lesion involves Left Main (stenosis >50%)
  • Percutaneous coronary intervention (PCI) with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis
  • Target coronary vessel provides collaterals to a chronically occluded vessel
  • Coronary angiography was not performed per standard of care at a cine frame rate of at least 7 frames per second
  • Presence of aortic damping
  • Distortion of the waveform
  • Less than two different angiographic views for each lesion of interest in the Left Circumflex Artery (LCX), Left Anterior Descending Artery (LAD), or Right Coronary Artery (RCA)
  • Lesion is not clearly visible

Treatment and study plan

MedHub AutocathFFR

Device

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.

Other names: AutocathFFR

Primary outcomes

  1. Per-Vessel Sensitivity of AutocathFFR vs. Invasive FFR

    Time frame: Day 1 (the day of the index invasive coronary angiography procedure)

    Sensitivity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR > 0.80 is considered "negative".

    Performance goal: lower bound of one-sided 97.5% confidence interval must exceed 80%.

  2. Per-Vessel Specificity of AutocathFFR vs. Invasive FFR

    Time frame: Day 1 (the day of the index invasive coronary angiography procedure)

    Specificity of the dichotomously scored AutocathFFR per vessel compared to the gold standard, invasive FFR measurements, where an FFR ≤ 0.80 is scored "positive" and an FFR > 0.80 is considered "negative".

    Performance goal: lower bound of one-sided 97.5% confidence interval must exceed 80%.

Secondary outcomes

  1. Per-Patient Sensitivity and Specificity

    Time frame: Day 1 (the day of the index invasive coronary angiography procedure)

    Per-patient sensitivity and specificity of the dichotomously scored AutocathFFR per vessel compared to gold standard, invasive FFR, where an FFR ≤ 0.80 is scored "positive" and an FFR > 0.80 is considered "negative".

  2. Sensitivity, Specificity, PPV, and NPV Including "No FFR" Output

    Time frame: Day 1 (the day of the index invasive coronary angiography procedure)

    Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of AutocathFFR, including cases where the device produces a "No FFR" output (failure to compute), compared to the gold standard, invasive FFR.

  3. Device Success Rate

    Time frame: Through study completion, up to 8 months

    Device success, measured as the ratio of completed versus initiated AutocathFFR index calculations.

  4. Device-Related Malfunctions

    Time frame: Through study completion, up to 8 months

    Number of device-related malfunctions recorded throughout the study, summarized descriptively.

Sponsors and collaborators

Lead sponsor

Medhub Ltd.

Industry

Registry information

Official study title

MedHub AutocathFFR United States Validation Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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