Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR) (NCT07763769) | Clinical Trial Compass
CompletedNot Applicable
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
United States277 participantsStarted 2025-11-04
Plain-language 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.
Who can participate
Age range
23 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Per-Vessel Sensitivity of AutocathFFR vs. Invasive FFR
Timeframe: Day 1 (the day of the index invasive coronary angiography procedure)
2
Per-Vessel Specificity of AutocathFFR vs. Invasive FFR
Timeframe: Day 1 (the day of the index invasive coronary angiography procedure)