Coronary Artery DiseaseFAVORIIINCT03656848

The FAVOR III China Study

A study testing QFR and Angiography in people with Coronary Artery Disease and Myocardial Ischaemia, run by China National Center for Cardiovascular Diseases at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Myocardial Ischaemia, Coronary Circulation
What is being tested?: QFR and Angiography
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,847 participants
Where: 1 siteChina
Study dates: 25 Dec 2018to 19 Feb 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

Read the 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.

Conditions: Coronary Artery Disease, Myocardial Ischaemia, Coronary Circulation, Coronary Stenosis, Percutaneous Coronary Intervention
Being tested: QFR, Angiography
Keywords: Quantitative Coronary Angiography, Quantitative Flow Ratio, Coronary Artery Disease, Myocardial Ischaemia, Percutaneous Coronary Intervention, Coronary Circulation
Medical subject headings: Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QFRDiagnostic test
Also called Quantitative Flow Ratio
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.
AngiographyDiagnostic test
Also called Coronary angiography
Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries

Study groups in NCT03656848
Study group	Role	What they receive
QFR-guided PCI group	Experimental	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. Receives: Diagnostic Test: QFR; Diagnostic Test: Angiography
Angiography-guided PCI group	Active comparator	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. Receives: Diagnostic Test: Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

MACE
A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization
Measured: 1 year

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Dec 201819 Feb 2025

First posted4 Sep 2018
Study start25 Dec 2018
Primary completion19 Feb 2021
Study completion19 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 3,847 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03656848
Sponsor's protocol ID: FAVOR III China - 2508
Acronym: FAVORIII
Status last verified: Dec 2022
First submitted: 31 Aug 2018
Last updated: 20 Dec 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
PubMed 27712739
Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.
PubMed 29980523
Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.
PubMed 29101020
Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
PubMed 19144937
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
PubMed 22924638
Song L, Tu S, Sun Z, Wang Y, Ding D, Guan C, Xie L, Escaned J, Fearon WF, Kirtane AJ, Serruys PW, Wijns W, Windecker S, Leon MB, Stone GW, Qiao S, Xu B; FAVOR III China Investigators. Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial. Am Heart J. 2020 May;223:72-80. doi: 10.1016/j.ahj.2020.02.015. Epub 2020 Feb 24.
PubMed 32179258
Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.
PubMed 34742368
Jin Z, Xu B, Yang X, Jia R, Meng S, Hu H, Deng Y, Cao X, Ruan Y, Han J, Liu J, Qu X, Zhou Y, Wang J, Fu G, Yu B, Wang Y, Guan C, Song L, Tu S, Qiao S, Stone GW; FAVOR III China Study Group. Coronary Intervention Guided by Quantitative Flow Ratio vs Angiography in Patients With or Without Diabetes. J Am Coll Cardiol. 2022 Sep 27;80(13):1254-1264. doi: 10.1016/j.jacc.2022.06.044.
PubMed 36137676
Song L, Xu B, Tu S, Guan C, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Zhang R, Liu J, Zhao Y, Wang Y, Dou K, Kirtane AJ, Wu Y, Wijns W, Yang W, Leon MB, Qiao S, Stone GW; FAVOR III China Study Group. 2-Year Outcomes of Angiographic Quantitative Flow Ratio-Guided Coronary Interventions. J Am Coll Cardiol. 2022 Nov 29;80(22):2089-2101. doi: 10.1016/j.jacc.2022.09.007. Epub 2022 Sep 19.
PubMed 36424680
Zhang H, Shi Y, Guan C, Cui J, Wu X, Chen L, Shen C, Yang J, Liu X, Jin Y, Wang L, Su X, Yang Q, Shen Z, Zhao Y, Dou K, Yang W, Wang J, Wu Y, Fearon WF, Tu S, Escaned J, Qiao S, Song L, Stone GW; FAVOR III China Study Group. Quantitative Flow Ratio- vs Angiography-Guided Percutaneous Coronary Intervention: A Secondary Analysis of the FAVOR III China Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639926. doi: 10.1001/jamanetworkopen.2026.39926.
PubMed 42911591
Zhang H, Guan C, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Liu J, Zhao Y, Wang Y, Dou K, Kirtane AJ, Wu Y, Yang W, Qiao S, Tu S, Stone GW, Song L; FAVOR III China Study Group. Angiographic Quantitative Flow Ratio-Guided Coronary Intervention: 5-Year Follow-Up From the FAVOR III China Randomized Trial. J Am Coll Cardiol. 2026 Jun 2:S0735-1097(26)06356-4. doi: 10.1016/j.jacc.2026.04.037. Online ahead of print.
PubMed 42268156
Zhang H, Shi W, Zhao Z, Niu G, Liu Z, Guan C, Xie L, Zou T, Cheng X, Guo N, Ye F, Wang L, Mi J, Tu S, Ge J, Song L, Wu Y; FAVOR III China Study Group. Prognostic Value of Angiographic Microcirculatory Resistance After Coronary Intervention: Insights From the FAVOR III China Trial. J Am Heart Assoc. 2026 Apr 21;15(8):e045639. doi: 10.1161/JAHA.125.045639. Epub 2026 Apr 7.
PubMed 41944160
Zhang R, Wang HY, Song L, Guan C, Yin D, Zhu C, Feng L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Zhao Y, Wang Y, Liu W, Qiao S, Tu S, Wijns W, Dou K; FAVOR III China Study Group. Rationales Behind Physiology-Guided Revascularization: Diagnostic Impact of Quantitative Flow Ratio in the FAVOR III China Trial. JACC Cardiovasc Interv. 2026 Feb 23;19(4):422-434. doi: 10.1016/j.jcin.2025.10.042. Epub 2025 Nov 20.
PubMed 41263729
Ding S, Zhou Z, Zou Z, Cheng F, Sheng X, Liu X, Guo L, Shen C, Zhang Y, Pan H, Xu Y, Chu M, Wang Y, Guan C, Tu S, Kirtane AJ, Qiao S, Song L, Stone GW, Pu J; FAVOR III China Study Group. Two-year outcomes of quantitative flow ratio-based physiology-guided percutaneous coronary intervention in patients with low-risk acute coronary syndrome: a prespecified secondary analysis of FAVOR III China. EClinicalMedicine. 2025 Aug 30;88:103461. doi: 10.1016/j.eclinm.2025.103461. eCollection 2025 Oct.
PubMed 40926902
Geng Y, Guan C, Jiang Y, Yang W, Yu B, Fu G, Pu J, Qu X, Zhang Q, Zhao Y, Yu L, Huang Y, Tu S, Qiao S, Song L. Prognostic impact of guideline-directed medical therapy after functionally complete revascularisation in patients with obstructive coronary artery diseases. Heart. 2026 Feb 12;112(5):270-277. doi: 10.1136/heartjnl-2025-325670.
PubMed 40780826

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease (The FAVOR III China Study)
ClinicalTrials.gov ID: NCT03656848
Acronym / sponsor ID: FAVORIII / FAVOR III China - 2508
Conditions: Coronary Artery Disease, Myocardial Ischaemia, Coronary Circulation, Coronary Stenosis, Percutaneous Coronary Intervention
Keywords: Quantitative Coronary Angiography, Quantitative Flow Ratio, Coronary Artery Disease, Myocardial Ischaemia, Percutaneous Coronary Intervention, Coronary Circulation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 3,847 participants (actual)
Lead sponsor: China National Center for Cardiovascular DiseasesOther government
Study start: 25 Dec 2018 (actual)
Primary completion: 19 Feb 2021 (actual)
Study completion: 19 Feb 2025 (estimated)
First posted: 4 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QFR-guided PCI group	Experimental	Diagnostic Test: QFR, Diagnostic Test: AngiographyIf 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.
Angiography-guided PCI group	Active comparator	Diagnostic Test: AngiographyIf 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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
At least one lesion is present of DS% ≥50% and ≤90% in one major native epicardial coronary artery and supplying viable myocardium

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QFRAlso: Quantitative Flow RatioQFR 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.	Diagnostic test	QFR-guided PCI group
AngiographyAlso: Coronary angiographyCoronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries	Diagnostic test	Angiography-guided PCI group, QFR-guided PCI group

Primary outcome

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

10 secondary outcomes

MACE excluding peri-procedural MI (Major secondary endpoint)
Time frame: 1 year
MACE
Time frame: 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
MI
Time frame: 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
Any coronary artery revascularization
Time frame: 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
The PCI strategy changes based on the QFR and 3D-QCA
Time frame: During the procedure
Cost during 1-year follow-up
Time frame: 1 month, 6 months, 1 year
Quality-adjusted-life-years (QALYs) index
Time frame: 1 month, 6 months, 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
Background: PubMed 27712739Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.
Background: PubMed 29980523Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.
Background: PubMed 29101020Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.
Background: PubMed 19144937Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
Background: PubMed 22924638De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
Background: PubMed 32179258Song L, Tu S, Sun Z, Wang Y, Ding D, Guan C, Xie L, Escaned J, Fearon WF, Kirtane AJ, Serruys PW, Wijns W, Windecker S, Leon MB, Stone GW, Qiao S, Xu B; FAVOR III China Investigators. Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial. Am Heart J. 2020 May;223:72-80. doi: 10.1016/j.ahj.2020.02.015. Epub 2020 Feb 24.
Results publication: PubMed 34742368Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.
Results publication: PubMed 36137676Jin Z, Xu B, Yang X, Jia R, Meng S, Hu H, Deng Y, Cao X, Ruan Y, Han J, Liu J, Qu X, Zhou Y, Wang J, Fu G, Yu B, Wang Y, Guan C, Song L, Tu S, Qiao S, Stone GW; FAVOR III China Study Group. Coronary Intervention Guided by Quantitative Flow Ratio vs Angiography in Patients With or Without Diabetes. J Am Coll Cardiol. 2022 Sep 27;80(13):1254-1264. doi: 10.1016/j.jacc.2022.06.044.
Results publication: PubMed 36424680Song L, Xu B, Tu S, Guan C, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Zhang R, Liu J, Zhao Y, Wang Y, Dou K, Kirtane AJ, Wu Y, Wijns W, Yang W, Leon MB, Qiao S, Stone GW; FAVOR III China Study Group. 2-Year Outcomes of Angiographic Quantitative Flow Ratio-Guided Coronary Interventions. J Am Coll Cardiol. 2022 Nov 29;80(22):2089-2101. doi: 10.1016/j.jacc.2022.09.007. Epub 2022 Sep 19.
Derived from this study: PubMed 42911591Zhang H, Shi Y, Guan C, Cui J, Wu X, Chen L, Shen C, Yang J, Liu X, Jin Y, Wang L, Su X, Yang Q, Shen Z, Zhao Y, Dou K, Yang W, Wang J, Wu Y, Fearon WF, Tu S, Escaned J, Qiao S, Song L, Stone GW; FAVOR III China Study Group. Quantitative Flow Ratio- vs Angiography-Guided Percutaneous Coronary Intervention: A Secondary Analysis of the FAVOR III China Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639926. doi: 10.1001/jamanetworkopen.2026.39926.
Derived from this study: PubMed 42268156Zhang H, Guan C, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Liu J, Zhao Y, Wang Y, Dou K, Kirtane AJ, Wu Y, Yang W, Qiao S, Tu S, Stone GW, Song L; FAVOR III China Study Group. Angiographic Quantitative Flow Ratio-Guided Coronary Intervention: 5-Year Follow-Up From the FAVOR III China Randomized Trial. J Am Coll Cardiol. 2026 Jun 2:S0735-1097(26)06356-4. doi: 10.1016/j.jacc.2026.04.037. Online ahead of print.
Derived from this study: PubMed 41944160Zhang H, Shi W, Zhao Z, Niu G, Liu Z, Guan C, Xie L, Zou T, Cheng X, Guo N, Ye F, Wang L, Mi J, Tu S, Ge J, Song L, Wu Y; FAVOR III China Study Group. Prognostic Value of Angiographic Microcirculatory Resistance After Coronary Intervention: Insights From the FAVOR III China Trial. J Am Heart Assoc. 2026 Apr 21;15(8):e045639. doi: 10.1161/JAHA.125.045639. Epub 2026 Apr 7.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bo Xu, MBBS principal investigator

Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Shubin Qiao, MD principal investigator

Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing QFR and Angiography in people with Coronary Artery Disease and Myocardial Ischaemia, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03656848, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.