This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of 120 patients with intermediated left main coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of left main coronary artery stenosis will be analyzed.
Study Type
OBSERVATIONAL
Enrollment
120
UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine.
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Select A State, China
RECRUITINGDiagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Diagnostic accuracy is defined as UFFR (≤0.80 or \>0.80) to identify hemodynamically-significant left main coronary stenosis with FFR (≤0.80 or \>0.80) as the reference standard.
Time frame: Immediately after the procedure
Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR \> 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR \> 0.80).
Time frame: Immediately after the procedure
Comparison of sensitivity and specificity of UFR and IVUS-derived minimal lumen area (MLA) in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR \> 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR \> 0.80).
Time frame: Immediately after the procedure
The AUC of UFR for left main coronary stenosis with FFR as the gold standard
AUC is defined as the area under the receiver-operating characteristic curve.
Time frame: Immediately after the procedure
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