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The FAVOR III China Study (FAVORIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656848
Recruitment Status : Active, not recruiting
First Posted : September 4, 2018
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bo Xu, China National Center for Cardiovascular Diseases

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischaemia Coronary Circulation Coronary Stenosis Percutaneous Coronary Intervention Diagnostic Test: QFR Diagnostic Test: Angiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This is a blinded clinical trial. Subjects and clinical assessor will be blinded to the assignment results. All the study site personnel will receive training for the blinding measures before the trial initiating. In addition to standard procedural sedation, music-playing headphones will be worn by the patient during the whole procedure, and patients in both groups will be preset a 10 minutes delay for QFR calculation before the PCI procedure, a lesion/device evaluation form is required to fill in during the period in both groups, to reduce the possibility of unblinding. All the study site personnel will be trained not to disclose the treatment assignment to the subject in any unplanned time. Subject blinding should be maintained until the one-year follow-up visit for all registered subjects is completed.
Primary Purpose: Diagnostic
Official Title: Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease (The FAVOR III China Study)
Actual Study Start Date : December 25, 2018
Estimated Primary Completion Date : February 19, 2021
Estimated Study Completion Date : February 19, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Coronary angiography




Primary Outcome Measures :
  1. MACE [ Time Frame: 1 year ]
    A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization


Secondary Outcome Measures :
  1. MACE excluding peri-procedural MI (Major secondary endpoint) [ Time Frame: 1 year ]
    all-cause mortality, any spontaneous myocardial infarction and any ischemia-driven revascularization

  2. Death [ Time Frame: 1 month, 6 months, 1 year, 2 years and 3 years ]
    Cardiovascular, non-cardiovascular and undetermined death

  3. MI [ Time Frame: 1 month, 6 months, 1 year, 2 years and 3 years ]
    Target vessel related and non-target vessel related MI

  4. Target vessel revascularization (TVR) [ Time Frame: 1 month, 6 months, 1 year, 2 years and 3 years ]
    The ischemia driven and non-ischemia driven TVR

  5. Any coronary artery revascularization [ Time Frame: 1 month, 6 months, 1 year, 2 years and 3 years ]
    The The ischemia driven and non-ischemia driven Revascularization

  6. Definite or probable stent thrombosis [ Time Frame: 1 month, 6 months, 1 year, 2 years and 3 years ]
    Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase according to the Academic Research Consortium (ARC)-2

  7. 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)

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656848


Locations
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China, Beijing
Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100037
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bo Xu, Director, Catheterization Laboratories, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03656848    
Other Study ID Numbers: FAVOR III China - 2508
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bo Xu, China National Center for Cardiovascular Diseases:
Quantitative Coronary Angiography
Quantitative Flow Ratio
Coronary Artery Disease
Myocardial Ischaemia
Percutaneous Coronary Intervention
Coronary Circulation
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes