The FAVOR II China Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-13

Study Completion Date

2017-07-20

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Arteriosclerosis Coronary Disease Arterial Occlusive Diseases Heart Diseases Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fractional Flow Reserve (FFR)

FFR measured by pressure wire, QFR computed by coronary angiographic images

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Quantitative Flow Ratio (QFR)

Eligibility Criteria

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Inclusion Criteria

General Criteria:

* Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI
* Age \> 18 years
* Able to provide signed informed consent

* At least one stenosis with diameter stenosis of 30%-90% by visual estimate
* Reference vessel size \> 2 mm in stenotic segment by visual estimate

Exclusion Criteria

General Criteria:

* Ineligible for diagnostic intervention or FFR examination
* Myocardial infarction within 72 hours
* Severe heart failure (NYHA≥III)
* S-creatinine\>150µmol/L or GFR\<45 ml/kg/1.73m2
* Allergy to contrast agent or adenosine
* Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation

* The interrogated stenosis is caused by myocardial bridge
* Ostial lesions less than 3 mm to the aorta
* Side branches of the bifurcation lesions with Median Classification of 111 or 101
* Poor angiographic image quality precluding contour detection
* Severe overlap of stenotic segments
* Severe tortuosity of target vessel

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No