The FAVOR II China Study

July 25, 2017 updated by: fuwaihospital, China National Center for Cardiovascular Diseases

Functional Diagnostic Accuracy of Quantitative Flow Ratio in On-line Assessment of Coronary Stenosis (The FAVOR II China Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General hospital
      • Beijing, China
        • Peking University Third Hospital
      • Guangzhou, China
        • Guangdong General Hospital
      • Shanghai, China
        • Shanghai Chest Hospital, Shanghai Jiao Tong University
    • Beijing
      • Beijing, Beijing, China
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis

Description

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

Angiographic inclusion criteria:

  • 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

Angiographic exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.
Time Frame: 1 hour
Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In comparison to online 2D QCA, sensitivity and specificity of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard
Time Frame: 1 hour

Sensitivity: Proportion of patients with positive QFR of FFR positive patients (true positives) compared to proportion of patients with positive percentual diameter stenosis (DS%) assessed by 2D QCA of FFR positive patients (true positives).

Specificity: Proportion of patients with negative QFR of FFR negative patients (true negatives) compared to proportion of patients with negative DS% assessed by 2D QCA of FFR negative patients (true negatives).
1 hour
The numerical difference between online QFR and core lab QFR.
Time Frame: 1 hour
1 hour
The numerical difference between online QFR and FFR.
Time Frame: 1 hour
1 hour
The area under the receiver operating characteristic curve of online QFR in determining presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard
Time Frame: 1 hour
Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.
1 hour
Feasibility of online computation of QFR
Time Frame: 1 hour
Percentage of successful QFR in all vessels sent to QFR computation
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Pulse Medical Imaging Technology (Shanghai) Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2017

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAVOR II -1608

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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