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
Study Type
OBSERVATIONAL
Enrollment
250
iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland
Contilia heart and vascular center
Essen, North Rhine-Westphalia, Germany
RECRUITINGDiagnostic performance of QFR in comparison to iFR
reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR
Time frame: 1 hour
QFR- iFR diagnostic grey zone calculation.
QFR limits for achieving 95% sensitivity and specificity in comparison to iFR
Time frame: 1 hour
Diagnostic performance of QFR in comparison to FFR
reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to FFR
Time frame: 1 hour
QFR- FFR diagnostic grey zone calculation.
QFR limits for achieving 95% sensitivity and specificity in comparison to FFR
Time frame: 1 hour
Diagnostic performance of iFR in comparison to FFR
reported as sensitivity, specificity, positive and negative likelihood ratio of iFR according to FFR
Time frame: 1 hour
iFR- FFR diagnostic grey zone calculation.
iFR limits for achieving 95% sensitivity and specificity in comparison to FFR
Time frame: 1 hour
effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.
Influence of minimum luminal area (MLA), percentage area stenosis, lesion length, and minimum luminal diameter (MLD) and percentage diameter stenosis in the prediction of QFR-iFR-FFR disagreement.
Time frame: 1 hour
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Effect of lesion location on QFR-iFR-FFR disagreement.
Evaluation of lesion location in the prediction of QFR-iFR-FFR disagreement.
Time frame: 1 hour
Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.
Evaluation of p20-DAC2 score in proximal and mid-LAD stenosis in in the prediction of QFR-iFR-FFR disagreement.
Time frame: 1 hour