Trials / Completed
CompletedNCT06039748
Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
Diagnostic Performance of Angiography-Derived Quantitative Functional Assessment Compared to Pressure-Derived Fractional Flow Reserve and Index of Microcirculatory Resistance: The FAIR Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 330 (actual)
- Sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Coronary Artery Disease
- Heart Diseases
- Cardiovascular Diseases
- Arteriosclerosis
- Coronary Stenosis
- Vascular Diseases
- Ischemia
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | AngioQFA | FFR measured by pressure wire, AngioQFA computed by coronary angiographic images |
Timeline
- Start date
- 2023-09-13
- Primary completion
- 2024-01-14
- Completion
- 2024-01-14
- First posted
- 2023-09-15
- Last updated
- 2025-05-16
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06039748. Inclusion in this directory is not an endorsement.