N/A
Completed N=75
Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
Atherosclerosis, Coronary
Source: ClinicalTrials.gov NCT03149042 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Comparison of CT Based FFR With Invasive FFR, ROC Analysis — 0.8 probability of accurate diagnosis
Summary
Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. Using patient specific 3D printed coronary phantoms would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study includes ~50 patients over a year and half at GVI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of CT Based FFR With Invasive FFR, ROC Analysis |
0.8 | — |
| PRIMARY Comparison of CT Based FFR With Invasive FFR, Correlation Analysis |
0.75 | — |
| PRIMARY Comparison of CT Based FFR With Invasive FFR, Sensitivity |
82.61 | — |
| PRIMARY Comparison of CT Based FFR With Invasive FFR, Specificity |
76.32 | — |
| SECONDARY Comparison of CT Based FFR With Bench-top FFR Using 3D Printed Patient Specific Phantoms |
0.64 | — |
| SECONDARY Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, ROC Analysis |
0.81 | — |
| SECONDARY Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Pearson Correlation |
0.71 | — |
| SECONDARY Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Sensitivity |
86.96 | — |
| SECONDARY Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Specificity |
97.37 | — |
Eligibility Criteria
Inclusion Criteria
- All the patients >18 yrs of age , who are undergoing CCTA and angio-FFR. Patients who are (1) scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital or (2) clinically mandated CTA will be screened.
Exclusion Criteria
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- atrial fibrillation,
- Renal insufficiency (estimated glomerular filtration rate (GFR) <60 ml/min/1.73 m2),
- Active Bronchospasm prohibiting the use of beta blockers
- Morbid obesity (body mass index 40 kg/m2)
- Contraindications to iodinated contrast.
- Emergencies requiring immediate intervention or patients unable to consent.
- Patients not showing coronary calcium during Calcium Scoring procedures
Data sourced from ClinicalTrials.gov (NCT03149042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.