Trials / Completed
CompletedNCT03191708
The FAVOR II China Study
Functional Diagnostic Accuracy of Quantitative Flow Ratio in On-line Assessment of Coronary Stenosis (The FAVOR II China Study)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 308 (actual)
- Sponsor
- China National Center for Cardiovascular Diseases · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference standard.
Detailed description
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography. Lesions are often quantified by QCA, but fractional flow reserve is increasingly used to assess functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperemia). The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire, the cost of the wire, and the drug inducing hyperemia limits more widespread adoption. QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections. The FAVOR Pilot study (Tu et al.) showed promising results for core laboratory QFR analysis in selected patients. However, the accuracy of QFR when assessed online in the catheterization laboratory is unknown. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference standard. It is a prospective and multi-center trial with a total of 308 patients conducted at 5 Chinese centers.
Conditions
- Coronary Artery Disease
- Myocardial Ischemia
- Cardiovascular Diseases
- Arteriosclerosis
- Coronary Disease
- Arterial Occlusive Diseases
- Heart Diseases
- Vascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Fractional Flow Reserve (FFR) | FFR measured by pressure wire, QFR computed by coronary angiographic images |
Timeline
- Start date
- 2017-06-13
- Primary completion
- 2017-07-20
- Completion
- 2017-07-20
- First posted
- 2017-06-19
- Last updated
- 2017-07-26
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03191708. Inclusion in this directory is not an endorsement.