MedHub AutocathFFR United States Validation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medhub Ltd.
- Enrollment
- 277
- Locations
- 4
- Primary Endpoint
- Per-Vessel Sensitivity of AutocathFFR vs. Invasive FFR
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 23 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
Arms & Interventions
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.
Intervention: MedHub AutocathFFR (Device)
Outcomes
Primary Outcomes
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%.
Secondary Outcomes
- 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)