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

NCT07763769 | Completed FDA Device

• 1 other identifier: CLN-FFR-005
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 4

Brief 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

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

Keywords

Fractional Flow Reserve; FFR; AutocathFFR; Coronary Angiography

Outcome Measures

Primary Outcomes (2)

• 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%.

  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%.

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

Secondary Outcomes (4)

• Per-Patient Sensitivity and Specificity

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

• Sensitivity, Specificity, PPV, and NPV Including "No FFR" Output

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

• Device Success Rate

  Through study completion, up to 8 months

• Device-Related Malfunctions

  Through study completion, up to 8 months

Study Arms (1)

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

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.

Also known as: AutocathFFR

AutocathFFR Validation Cohort

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medhub Ltd.: lead

Study Sites (4)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Hector M. Garcia-Garcia, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 13, 2026
• Study Start: November 4, 2025
• Primary Completion: June 29, 2026
• Study Completion: June 29, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)