The FAVOR III China Study (FAVORIII)
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| ClinicalTrials.gov Identifier: NCT03656848 |
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Recruitment Status :
Active, not recruiting
First Posted : September 4, 2018
Last Update Posted : December 20, 2022
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| Condition or disease | Intervention/treatment | Phase |
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| Coronary Artery Disease Myocardial Ischaemia Coronary Circulation Coronary Stenosis Percutaneous Coronary Intervention | Diagnostic Test: QFR Diagnostic Test: Angiography | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 3847 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 |
| Actual Primary Completion Date : | February 19, 2021 |
| Estimated Study Completion Date : | February 19, 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 |
- MACE [ Time Frame: 1 year ]A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization
- MACE excluding peri-procedural MI (Major secondary endpoint) [ Time Frame: 1 year ]all-cause mortality, any spontaneous myocardial infarction and any ischemia-driven revascularization
- 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
- Death [ Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years ]Cardiovascular, non-cardiovascular and undetermined death
- 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
- 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
- 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
- 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
- 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)
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| China, Beijing | |
| Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | |
| Beijing, Beijing, China, 100037 | |
| 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 |
Other Publications:
| 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: | December 20, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Quantitative Coronary Angiography Quantitative Flow Ratio Coronary Artery Disease |
Myocardial Ischaemia Percutaneous Coronary Intervention Coronary Circulation |
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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 |