This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.
285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
285
Fractional flow reserve measured during cardiac catheterization
Spring Hill Hospital
Mobile, Alabama, United States
Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone
Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values \>0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and \<50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.
Time frame: 1 day
Diagnostic Performance of CCTA Plus FFRCT at the Subject Level
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard.
Time frame: 1 day
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