Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04731285
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2020-10-07
Brief Title:
Evaluation of Accuracy of CFD-based RuiXin-FFR by Comparing With Pressure-wire-based FFR
Sponsor:
Beijing Anzhen Hospital
Organization:
Beijing Anzhen Hospital
Study Overview
Official Title:
Accuracy of RuiXin-FFR by Comparing With Pressure-wire-based FFR in Detecting Hemodynamically Significant Stenosis A Prospective Multicenter Study
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 FFR08 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-FFR08 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None