Coronary Artery DiseaseNCT07763769
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
An observational study of Coronary Artery Disease and Stable Angina, run by Medhub Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Coronary Artery Disease, Stable Angina, Unstable Angina
- What is being tested?
- MedHub AutocathFFR
- Type of treatment
- Medical device
- How many people
- 277 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Nov 2025to 29 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Virginia Health System
Charlottesville, Virginia, 22908
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: MedHub AutocathFFR United States Validation Study
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:
Read more
- 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
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST-Elevation Myocardial Infarction
- Being tested
- MedHub AutocathFFR
- Keywords
- Fractional Flow Reserve, FFR, AutocathFFR, Coronary Angiography
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedHub AutocathFFRDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MedHub AutocathFFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Day 1 (the day of the index invasive coronary angiography procedure)
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%.
Measured: Day 1 (the day of the index invasive coronary angiography procedure)
Secondary outcomes (4)
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".
Measured: Day 1 (the day of the index invasive coronary angiography procedure)
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.
Measured: Day 1 (the day of the index invasive coronary angiography procedure)
Device Success Rate
Device success, measured as the ratio of completed versus initiated AutocathFFR index calculations.
Measured: Through study completion, up to 8 months
Device-Related Malfunctions
Number of device-related malfunctions recorded throughout the study, summarized descriptively.
Measured: Through study completion, up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start4 Nov 2025
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medhub Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hector M. Garcia-Garcia, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763769
- Sponsor's protocol ID
- CLN-FFR-005
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MedHub AutocathFFR United States Validation Study
- ClinicalTrials.gov ID
- NCT07763769
- Acronym / sponsor ID
- CLN-FFR-005
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST-Elevation Myocardial Infarction
- Keywords
- Fractional Flow Reserve, FFR, AutocathFFR, Coronary Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Medhub Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AutocathFFR Validation Cohort | – | Device: MedHub AutocathFFRAdult 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. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedHub AutocathFFRAlso: AutocathFFRMedHub 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. | Device | AutocathFFR Validation Cohort |
Primary outcome
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%.
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%.
4 secondary outcomes
Per-Patient Sensitivity and Specificity
Time frame: Day 1 (the day of the index invasive coronary angiography procedure)
Sensitivity, Specificity, PPV, and NPV Including "No FFR" Output
Time frame: Day 1 (the day of the index invasive coronary angiography procedure)
Device Success Rate
Time frame: Through study completion, up to 8 months
Device-Related Malfunctions
Time frame: Through study completion, up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector M. Garcia-Garcia, MD principal investigator
Medstar Health Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Stable Angina, run by Medhub Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-Vessel Sensitivity of AutocathFFR vs. Invasive FFR (time frame: Day 1 (the day of the index invasive coronary angiography procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.