Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06039748
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-15
First Post:
2023-09-10
Brief Title:
Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR The FAIR Study
Sponsor:
Shenzhen Raysight Intelligent Medical Technology Co Ltd
Organization:
Shenzhen Raysight Intelligent Medical Technology Co Ltd
Study Overview
Official Title:
Diagnostic Performance of Angiography-Derived Quantitative Functional Assessment Compared to Pressure-Derived Fractional Flow Reserve and Index of Microcirculatory Resistance The FAIR Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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 angiography-derived FFR assessment AngioQFA is a novel technique for physiological lesion assessment based on 3-dimensional 3D quantitative coronary angiography QCA and virtual hyperemic flow derived from contrast frame count without drug-induced hyperemia The goal of this prospective multicenter trial is to compare the diagnostic performance of AngioQFA with invasive FFR as the reference standard The secondary purpose is to compare the diagnostic accuracies of the computational fluid dynamics CFD-based index of microcirculatory resistance IMR using wire-based IMR as the reference standard
Detailed Description:
None
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