NCT04731285

Evaluation of Accuracy of CFD-based RuiXin-FFR by Comparing With Pressure-wire-based FFR

Accuracy of RuiXin-FFR by Comparing With Pressure-wire-based FFR in Detecting Hemodynamically Significant Stenosis: A Prospective Multicenter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 316 (actual)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Coronary Artery Disease (CAD) is the top killer nowadays. Pressure-wire-based Fractional Flow Reserve (FFR) is the gold standard for measuring ischemia in coronary arteries. CFD-based RuiXin-FFR, which is noninvasive, is developed recently. But its accuracy is not verified. This is a multi-center and prospective study to evaluate the sensitivity, specificity, and accuracy of CFD-based RuiXin-FFR compared with wire-based FFR.

Detailed description

The participants are entered with suspended CAD and angiography ischemia between 30%-90% from 6 hospitals in China. Pressure-wire-based FFR is conducted in the standard protocol by each hospital. FFR\>0.8 is chosen as the threshold to indicate non-ischemia. CFD-based RuiXin-FFR is performed by Raysight Medical (Shenzhen, China). CT images are acquired in a standard protocol by each hospital. Images with poor quality are excluded in this trial. Based on these images, RuiXin-FFR reconstructs the 3D model of coronary trees and obtains RuiXin-FFR values by conducting CFD simulations in a blinded fashion. RuiXin-FFR\>0.8 is chosen as the threshold to indicate non-ischemia as well. By comparing the clinical diagnosis outcome of pressure-wire-based FFR and CFD-based RuiXin-FFR, the sensitivity and specificity of the RuiXin-FFR are obtained, which is the primary end point of this trial. The secondary end point includes the measurement of accuracy, NPV, PPV and ROC of the RuiXin-FFR.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia
• Myocardial Fractional Flow Reserve

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pressure wire fractional flow reserve	Pressure wire is inserted into coronary arteries. The ratio of the average distal pressure and average aorta pressure is FFR.
DIAGNOSTIC_TEST	CFD-based RuiXin-FFR	CT-FFR was evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour

Timeline

• Start date: 2019-03-13
• Primary completion: 2020-05-14
• Completion: 2020-08-31
• First posted: 2021-01-29
• Last updated: 2021-09-05

Locations

1 site across 1 country: China