Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
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.
Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT
 estimation can aid in the severity estimation of significant atherosclerotic lesions.
 Following this trend, the investigators recently developed a collaboration between Brigham
 and Women's Hospital (BWH) and Gates Vascular Institute (GVI). The investigators 3D-printed
 patient specific coronary phantoms at (GVI) and scanned them with a Toshiba Aquilion scanner
 to test several aspects of the contrast opacification gradients using a method established at
 BWH. The initial results showed strong correlation between the flow in the phantom and
 opacification gradients. The investigators believe that this approach could be further
 developed to test and validate FFR-CT algorithms. Currently, FFR-CT algorithms can only be
 optimized using theoretical models and can only be validated in large multi-center clinical
 trials. This phantom approach 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. The approach is to use
 the infrastructure at GVI to perform a detailed validation of the FFR-CT method using 3D
 printed patient specific phantoms. The subject enrollment criteria is: at least one CCTA, at
 least one lesion with >50% stenosis or 30-50% and an angio based FFR. Each patient will have
 a 3D phantom printed, containing the culprit lesion and used in a benchtop flow analysis.
 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 will include ~50 patients over
 a year and half at GVI. The investigators are confident that this approach performed via
 3D-phantom testing will prove the validity of FFR-CT based measurements as well as develop a
 new standard for validating FFR-CT algorithms.
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