NCT07763769Completed
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
MedHub AutocathFFR United States Validation Study
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 277 (actual)
- First submitted
- 6 Aug 2026
- Start date
- 4 Nov 2025
- Primary completion date
- 29 Jun 2026
- Lead sponsor
- Medhub Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT07763769
What you commit to
- Study type: Observational
- Participants enrolled: 277
- From 4 Nov 2025 to the primary completion date, 29 Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Angiogram not obtained on a United States Food and Drug Administration (FDA)-cleared C-arm angiography system
- 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
- Arteries supplying akinetic or severe hypokinetic territories on target lesion, if already known based on prior imaging
Other illness
- Subject presents with an ST-elevation myocardial infarction (STEMI)
- Thrombolysis in Myocardial Infarction (TIMI) flow grade equal to or lower than 2 at baseline
Lab values
- Known left ventricular ejection fraction (LVEF) ≤ 30%
Other
- 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
- Chronic total occlusion (CTO) in target vessel
- 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
Who the study is looking for
- 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
Age in the registry: 23 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northeast Georgia Medical Center Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.