ClinicalTrials.gg
CompletedNCT07763769Updated Aug 13, 2026

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

An observational study in Coronary Artery Disease, Stable Angina and Unstable Angina, sponsored by Medhub Ltd.. Completed at 4 sites in United States. Open to participants aged 23 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Medhub Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
277
Ages
23 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,105 studies in Coronary Artery Disease with a site in United States — 102 open to participants now, 147 under way, 10 of them phase 3. Coronary Artery Disease · United States.

Enrollment
142nd of 357
277 · median 186
Started
2025
with 31 others
Observational
358 of 1,105
34 open now
Registered
1,098th of 1,105
by date

Among the 1,105 studies in Coronary Artery Disease with a site in United States, this one is the 142nd largest by enrollment of the 357 observational ones that give a count, is one of 32 that started in 2025, is one of 358 observational ones, and was the 1,098th registered.

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

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Open to participants now

102 of the 1,105 studies in Coronary Artery Disease with a site in United States are open now. Recruiting first, the newest first:

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A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 23 Years and older · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Coronary Artery Disease
  • Stable Angina
  • Unstable Angina
  • Non-ST-Elevation Myocardial Infarction

Keywords

  • Fractional Flow Reserve
  • FFR
  • AutocathFFR
  • Coronary Angiography
04

Who can participate

Ages eligible
23 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Angiograms from adult subjects with stable angina, unstable angina or NSTEMI who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured to assess the hemodynamic significance of suspected coronary lesions.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
277 participants (actual)
Patient registry
No

Groups and cohorts

  • AutocathFFR Validation Cohort

    Adult subjects with stable angina, unstable angina or NSTEMI who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured to assess the hemodynamic significance of suspected coronary lesions.

    Device: MedHub AutocathFFR

Interventions

  • DeviceMedHub 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.

    Also known as: AutocathFFR

06

What researchers measure

Primary outcomes

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

    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%.

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

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

    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%.

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

Secondary outcomes

  1. Per-Patient Sensitivity and Specificity

    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".

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

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

    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.

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

  3. Device Success Rate

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

    Time frame: Through study completion, up to 8 months

  4. Device-Related Malfunctions

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

    Time frame: Through study completion, up to 8 months

07

Study locations

4 sites
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
  • Northeast Georgia Medical Center
    Gainesville, Georgia 30501, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data (IPD) with other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2025 to primary completion in Jun 2026, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 13, 2026
StartActual
Nov 4, 2025
Primary completionActual
Jun 29, 2026
CompletionActual
Jun 29, 2026
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07763769
Lead sponsor
Medhub Ltd.
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Nov 4, 2025
Primary completion
Jun 29, 2026
Completion
Jun 29, 2026
Last update
Aug 13, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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