NCT06053944|Unknown
Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
FUNCTION II
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FUNCTION II
Sponsor study identifier
observational
120
1 country
1
Study Start
October 18, 2023
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2023
Actual (reported)September 26, 2023
Actual (reported)October 18, 2023
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Diagnostic 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.
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).
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
Immediately after the procedure
The AUC of UFR for left main coronary stenosis with FFR as the gold standard
Immediately after the procedure
UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine.
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Patients ≥ 18 years of age who will be admitted for coronary angiography and had an indication for FFR measurement at the Fuwai Hospital, Beijing, China, due to stable angina or unstable angina will be consecutively enrolled.
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Select A State, 100037, China
Jie Qian
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
First Submitted
September 17, 2023
First Posted
September 26, 2023
Study Start
October 18, 2023
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)IVUS VS CAG Guided PCI for Patients With LMB Lesion
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 22, 2024
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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