The FAVOR III China Study (FAVORIII)

December 16, 2022 updated by: Bo Xu, China National Center for Cardiovascular Diseases

Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease (The FAVOR III China Study)

The overall purpose of the FAVOR III China trial is to investigate if a strategy of quantitative flow ratio (QFR)-guided percutaneous coronary intervention (PCI) yields superior clinical outcome and cost-effectiveness compared to a strategy of standard coronary angiography-guided PCI in evaluation of patients with coronary artery disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The FAVOR III China is a prospective, multicenter, blinded, randomized, superiority clinical trial comparing the clinical outcome and cost-effectiveness of the two PCI strategies, QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only-guided (angiography-guided) strategy , in evaluation of patients with coronary artery disease (CAD). The study is adequately powered to detect if the primary outcome by the QFR-guided PCI strategy is superior to the standard angiography-guided PCI strategy. The hypothesis is that a QFR-guided PCI strategy results in superior clinical outcome, assessed by rate of Major Adverse Cardiac Events (MACE) defined as a composite of all-cause mortality, any myocardial infarction (MI) and any ischemia-driven revascularization at 1 year, compared to a standard angiography-guided PCI strategy. If QFR-guided strategy is shown to be superior to the angiography-guided strategy, the lower clinical costs and better clinical outcome by QFR may suggest it to be the preferred strategy for invasive functional evaluation of coronary artery stenosis.

The primary and major secondary endpoints will be analyzed in prespecified subgroups, including age, sex, diabetes, smoking status, acute coronary syndrome, body mass index, left ventricular ejection fraction, lesion location, length and reference vessel diameter, stenosis severity, multivessel disease, calcified lesion, bifurcation, tandem and bending/tortuous lesion, QFR gray zone (0.75-0.85), QFR based functional and residual functional SYNTAX score, residual QFR, center experience for invasive physiology, and learning experience with QFR.

For the purpose of protecting trial subjects and study personnel while maintaining trial data integrity during the coronavirus disease 2019 (COVID-19) pandemic, we particularly arranged an unscheduled telephone follow-up for all the participants, to evaluate the potential impact of the pandemic. Using a special designed follow-up questionnaire, all subjects were required to report the presence of COVID-19 infection and its related complications, any possible ischemia symptom, any hospitalization or outpatient visit, and interruption of cardiovascular medicine during this time (from Jan 20, 2019 to May 1, 2020). Clinical event committees (CEC) will update the working protocol to enable the re-adjudication of events from the onset of the pandemic to the end of the trial. All the events will be classified as related, possibly related, or not related to COVID-19 infection. To identify the interaction between COVID-19 pandemic and randomized revascularization strategy in the current study, several prespecified subsets will be added to the subgroups analysis, including COVID-19 positive vs. negative subjects, pre-pandemic vs. during pandemic vs. post-pandemic subjects, and the sites located at the high-risk region vs. low- to mediate-risk region.

Study Type

Interventional

Enrollment (Actual)

3847

Phase

  • Not Applicable

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
      • Beijing, Beijing, China, 100037
        • Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

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

Description

Inclusion Criteria:

General inclusion criteria:

  • Age ≥ 18 years
  • Stable or unstable angina pectoris, or post-acute myocardial infarction (≥ 72 hrs)
  • Signed written informed consent
  • Eligible for PCI by the operators

Angiographic inclusion criteria:

  • At least one lesion is present of DS% ≥50% and ≤90% in one major native epicardial coronary artery and supplying viable myocardium
  • Reference lumen diameter ≥ 2.5mm by visual assessment

Exclusion Criteria:

General exclusion criteria:

  • Cardiogenic shock or severe heart failure (NYHA ≥III)
  • Severely impaired renal function: creatinine > 150μmol/L or Cockcroft-Gault calculated GFR < 45 ml/kg/1.73 m2
  • Allergy to iodine-containing contrast agents
  • Pregnancy or intention to become pregnant during the course of the trial
  • Life expectancy less than one year

Angiographic exclusion criteria:

  • With only one coronary artery lesion（DS%>90%）with TIMI flow < 3
  • Target stenoses are culprit lesions related with acute myocardial infarction
  • Target stenoses in the vessel involving myocardial bridge
  • Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast filling
  • Severe overlap in the stenosed segment or severe tortuosity of any target vessel deemed unable for QFR measurement

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QFR-guided PCI group
If the patient is assigned to QFR-guided PCI, QFR is first measured in all coronary arteries with DS% ≥ 50% and ≤ 90%. Then PCI treatment is performed in lesions with QFR ≤ 0.80, and optimal medicine treatment is prescribed to those with QFR > 0.80. It is strongly recommended to select the device size based on the 3D-QCA measurements in this group.
Diagnostic test: QFR
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.
Other Names:
  • Quantitative Flow Ratio
Diagnostic test: Angiography
Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries
Other Names:
  • Coronary angiography
Active Comparator: Angiography-guided PCI group
If the patient is assigned to angiography-guided PCI, then the investigator performs PCI according to the stenosis severity based on visual assessment of the angiogram. No other functional tests such as FFR/iFR can be used for further assessment of the lesion before PCI.
Diagnostic test: Angiography
Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries
Other Names:
  • Coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 1 year
A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE excluding peri-procedural MI (Major secondary endpoint)
Time Frame: 1 year
all-cause mortality, any spontaneous myocardial infarction and any ischemia-driven revascularization
1 year
MACE
Time Frame: 1 month, 2 years, 3 years, 4 years and 5 years
A composite of all-cause mortality, any myocardial infarction and any ischemia-driven
1 month, 2 years, 3 years, 4 years and 5 years
Death
Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Cardiovascular, non-cardiovascular and undetermined death
1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
MI
Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Target vessel related and non-target vessel related MI
1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Target vessel revascularization (TVR)
Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
The ischemia driven and non-ischemia driven TVR
1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Any coronary artery revascularization
Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
The The ischemia driven and non-ischemia driven Revascularization
1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Definite or probable stent thrombosis
Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase according to the Academic Research Consortium (ARC)-2
1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
The PCI strategy changes based on the QFR and 3D-QCA
Time Frame: During the procedure
PCI strategy changes following QFR and three-dimension quantitative coronary angiography (3D-QCA)
During the procedure
Cost during 1-year follow-up
Time Frame: 1 month, 6 months, 1 year
Costs include direct clinical costs during the initial hospitalization and other resources used, main cardiovascular medication expenses, and outpatient and/or hospitalization expenses associated with MACE.
1 month, 6 months, 1 year
Quality-adjusted-life-years (QALYs) index
Time Frame: 1 month, 6 months, 1 year
QALYs determined using EuroQol five dimensions questionnaire (EQ-5D) in official Chinese version, to assess the quality of life.
1 month, 6 months, 1 year

Collaborators and Investigators

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

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Bo Xu, MBBS, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
  • Principal Investigator: Shubin Qiao, MD, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

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)

December 25, 2018

Primary Completion (Actual)

February 19, 2021

Study Completion (Anticipated)

February 19, 2025

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAVOR III China - 2508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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