Coronary Stenosis Clinical Trial
Official title:
A Clinical Trial on the Diagnostic Performance Based on CT-Derived Fractional Flow Reserve Score Analysis Software for Coronary Artery Stenosis
The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.
The present study is a single arm, open label, prospective trial. Measurement of FFR during
invasive cardiac catheterization represents the "gold standard" for assessment of the
hemodynamic significance of coronary artery lesions. As we know, the major disadvantage of
FFR is that it has to be measured invasively. CardioSimFFRct Analysis software is a
non-invasive method to determine FFR which computes the hemodynamic significance of Coronary
Artery Disease (FFRCT) from coronary computed tomography angiography（CCTA）data of the subject
by using computational fluid dynamics.The FFR derived from FFR-CT will be compared with
invasive FFR as gold standard.Moreover CardioSimFFRct also simplifies the coronary artery
into a one-dimensional piping model, omits grid engineering, and greatly reduces the
complexity of pretreatment.Based on the pressure loss along the pipe flow and the local
pressure loss, a fast method for FFR calculation in engineering is proposed. The calculation
time can be reduced to several minutes.
FFRct from CardioSimFFRct Analysis software is mainly based on CCTA images to image the
coronary arteries. Through three-dimensional reconstruction of the coronary arteries and
computational fluid Dynamics (CFD) technology, the simulation of blood flow in the blood
vessels is realized to extract the coronary blood flow reserve score (FFR).FFRct has the
following characteristics such as the FFR value can be measured noninvasively, without
additional damage to patients, avoiding the risks brought by invasive surgery, and the side
effects brought by drugs during invasive surgery.FFRct can realize the examination quickly,
save the time of doctors' coronary functional assessment, and simplify the process of
coronary functional assessment.It also has the function of three-dimensional reconstruction
of blood vessels, which makes it convenient for users to view the whole structure of coronary
arteries and make artificial correction.The results of FFRct have high repeatability and are
easy for users to evaluate.
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