Coronary Artery Disease Clinical Trial
Official title:
DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.
During coronary angiography, intermediate stenoses can not be adequately assessed by visual
assessment alone. It is necessary to evaluate the functional significance to guide their
treatment.
Fractional Flow Reserve (FFR) is the current gold standard for determining this functional
significance but its adoption in clinical practice remains low. The instantaneous wave-free
ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a
coronary stenosis with a pressure wire but without the need to induce hyperemia. Large
randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of
outcome.
Quantitative Flow Ratio (QFR) is another new method for evaluating the functional
significance of coronary stenosis It is a software-based analysis of conventional
angiographic images to estimate the pressure drop caused by a coronary stenosis. The
diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is
enrolling for confirmation.
A stepwise approach of QFR and iFR could make the functional assessment of intermediate
stenoses more practical and cost-effective. However before being used as a combination in
daily practice, QFR has to be validated in respect to iFR.
The primary objective of the trial is to investigate the diagnostic agreement between QFR and
the pressure wire-based iFR in a real world setting
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