Coronary Artery Stenosis Clinical Trial
This study will evaluate the effectiveness of CorCTA by comparing the results of the test with another imaging method called Fractional Flow Reserve (FFR), which is done as a part of the cardiac catheterization.
Invasive X-ray coronary angiography remains the "reference standard" for the evaluation of
coronary artery stenoses. Recently, coronary artery computed tomography angiography (CorCTA)
has been introduced as a non-invasive method for the evaluation of coronary artery stenoses
and has been shown to be highly accurate in stenosis detection when compared to invasive
X-ray angiography. While invasive X-ray angiography and CorCTA evaluate morphological
features of coronary arterial plaques, fractional flow reserve is an invasive measure of the
hemodynamic significance of a stenosis obtained in the catheterization laboratory by
measuring changes in intracoronary arterial pressure before and after maximal vasodilation
induced by intracoronary adenosine. An FFR value less than 0.75 has been shown to predict
ischemia in vascular beds distal to the stenosis by radionuclide perfusion modalities and
has been shown to be associated with worse outcomes. Therefore, FFR is considered to be an
invasive hemodynamic "reference standard" for the evaluation of the hemodynamic significance
of coronary arterial stenoses. While intravascular ultrasound (IVUS) can provide additional
morphological information in intermediate stenoses, it can not provide further functional
information and cannot be used in more significant stenoses as the IVUS probe cannot be
advanced through stenotic lesions.
We are currently conducting investigation in the validation of CorCTA against FFR in
intermediate coronary artery stenoses (40-70%) (see below under "Preliminary Data").
However, CorCTA has not been validated against invasive hemodynamic measurements of
fractional flow reserve in patients with stenoses >70% by invasive X-ray angiography. We
hypothesize that CorCTA-derived measurements are accurate in the diagnosis of
hemodynamically significant coronary artery stenoses, using FFR as the reference standard in
patients with coronary artery stenoses>70%.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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