Coronary Artery Stenosis Clinical Trial
Official title:
Comparison of Fractional Flow Reserve and Minimal Luminal Area by Intravascular Ultrasound in Evaluating Intermediate Coronary Artery Stenosis in Each Coronary Artery
This study will evaluate the relationship of Fractional Flow Reserve (FFR) and Minimal Lumen Area (MLA) by IntraVascular UltraSound (IVUS) by comparing the results of the both tests 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, intravascular ultrasound (IVUS) has been introduced as
an invasive method for the evaluation of coronary artery stenoses and has been shown to be
highly accurate in stenosis detection when compared to X-ray angiography. While invasive
X-ray angiography and IVUS evaluate morphological features of coronary arterial plaques,
fractional flow reserve (FFR) 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 intravenous 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 IVUS
can provide additional morphological information in intermediate stenoses, it can not
provide further functional information.
We are currently conducting investigation in the validation of IVUS against FFR in
intermediate coronary artery stenoses in each coronary arteries. However, the difference of
the values of IVUS data in each coronary artery, eg. left anterior descending artery or
right coronary artery, has not been validated against invasive hemodynamic measurements of
fractional flow reserve in patients with intermediate stenoses by invasive X-ray
angiography. We hypothesize that IVUS-derived measurements are interpreted differently in
each coronary arteries in the diagnosis of hemodynamically significant coronary artery
stenoses, using FFR as the reference standard in patients with coronary artery stenoses 40%<
and <70%.
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Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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