Comparison of UFR With QFR in Stable Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Flow Ratio Derived From Intravascular Ultrasound With Coronary Angiography in Stable Coronary Artery Disease: Correlation With Fractional Flow Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06322355
• Other study ID #: ZSUFR01
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions.

Description:

Coronary artery disease (CAD) remains a prevalent global health concern, necessitating precise diagnostic strategies for optimal patient management. Fractional Flow Reserve (FFR), defined as the distal-to-proximal pressure ratio across a coronary stenosis during maximal hyperemia and typically measured by a pressure guidewire during coronary angiography (CAG), is considered a gold standard tool for detecting ischemia-causing stenosis and guiding revascularization decisions. However, wire-based FFR has been significantly underutilized due to practical reasons, including its invasive nature and the requirement for hyperemia. Consequently, there is growing interest in developing and validating computational FFR from anatomical information derived from CAG and intravascular imaging modalities, such as intravascular ultrasound (IVUS).

Quantitative flow reserve (QFR), derived from CAG, has been extensively investigated and has demonstrated high diagnostic performance for detecting hemodynamically significant lesions. Beyond CAG, research has indicated that IVUS imaging can also be utilized for computing FFR. IVUS, a widely accepted and powerful modality for evaluating vessel luminal size and characterizing plaque morphology in the context of coronary intervention, has given rise to IVUS-based FFR, known as ultrasonic flow ratio (UFR). UFR has been recently developed, integrating an estimation of physiology with intravascular imaging in the same IVUS pullback. Despite the proven effectiveness of both UFR and QFR, there is currently no evidence supporting the superiority of one technique over the other. In the present study, investigators aim to compare the diagnostic performance of UFR and QFR for the detection of functionally significant coronary lesions, using conventional FFR as the gold standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who underwent both IVUS imaging and FFR measurement on the same artery

Exclusion Criteria:

• Inadequate quality of CAG or IVUS images for QFR or UFR calculation

• Left main or ostial right coronary artery lesion

• The use of balloon predilatation or stent placement prior to FFR measurement or IVUS imaging

• Incomplete IVUS pullback across the entire lesion segment

• The presence of a severe myocardial bridge (defined as =30% systolic diameter stenosis) in the examined vessel

• History of previous coronary artery bypass grafting,

• Left ventricular ejection fraction <35%

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasound
Invasive CAG was conducted following standard clinical procedures, encompassing multiple projections of both the left and right coronary arteries. The FFR was precisely measured using either an intracoronary pressure wire (Pressure Wire X; Abbott Vascular, Santa Clara, USA) or a rapid-exchange pressure microcatheter (Insight Lifetech, Shanghai, China) during peak hyperemia. This state of maximal hyperemia was achieved through the intravenous infusion of adenosine triphosphate (ATP) at a concentration of 150 µg/kg/min, administered via the forearm vein. Upon completion of the FFR assessment, the pressure wire or microcatheter was carefully retracted to the tip of the guiding catheter for a routine drift check. IVUS imaging was meticulously conducted using the iLab™ IVUS system, coupled with a 40-MHz OptiCross IVUS catheter (Boston Scientific, Fremont, USA), at a steady pullback speed of 0.5 mm/s.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare diagnostic performance of QFR with UFR		baseline
Secondary	Correlation and agreement between QFR and UFR		baseline