Coronary Artery DiseaseQFR-REALNCT07766434
A Prospective Multicenter Real-World Registry of Quantitative Flow Ratio-Guided Coronary REvascularization and QuAlity evaLuation
An observational study of Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This prospective, multicenter observational registry aims to establish a QFR-based quality control standard system for coronary revascularization in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2026to Jul 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% who present with asymptomatic ischemia, stable angina, unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction (>4 weeks after onset) and undergo PCI or receive conservative treatment at one of the participating centers.
Who may be able to join
- Age ≥18 years
- Coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% in patients with acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction >4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) who undergo PCI or receive conservative treatment
- Ability to understand the study design and provide written informed consent
Who cannot join
- ST-segment elevation myocardial infarction within 4 weeks of onset
- History of coronary artery bypass grafting (CABG) or planned CABG within 6 months
- Inability to undergo coronary angiography
- Non-cardiac cause with expected survival <1 year
- Other conditions that may interfere with follow-up (e.g., dementia, substance abuse including drug addiction and other drug dependencies)
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Clinical Research Center of Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Fuwai hospital, 010-88322674, kyy1220@126.com
About this study
This prospective, multicenter observational registry aims to establish a QFR-based quality control standard system for coronary revascularization in patients with coronary artery disease. The study will enroll over 10,000 patients with visually estimated at least one main branch coronary stenosis ≥50% from more than 50 centers across China (covering provincial, municipal, and county-level hospitals). Coronary angiographic images and intracoronary imaging (if available) will be collected and retrospectively analyzed by an independent core laboratory. The primary endpoint is QFR acquisition accessibility, defined as the mean of QFR usage proportion across centers.
Read the detailed description
This is a prospective, multicenter, observational registry study conducted at more than 50 centers across China. Patients with coronary angiography showing visually estimated at least one main branch stenosis ≥50% who undergo PCI or receive conservative treatment for acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction >4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) will be consecutively enrolled. Coronary angiographic images will be submitted to an independent core laboratory for retrospective QFR analysis. The study will establish a QFR-based quality control standard system for coronary revascularization.
Prespecified subgroup analyses will be performed to assess the concordance rates, overtreatment, and undertreatment rates between clinical decisions and offline core laboratory QFR, and to explore heterogeneity across hospital levels, clinical presentations, disease complexity, target vessel, operator annual PCI volume, QFR image analyzability, and lesion morphology. Other prespecified subgroups will be analyzed for the primary and secondary endpoints, 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.
- Conditions
- Coronary Artery Disease
- Keywords
- Quantitative Coronary Angiography, Quantitative Flow Ratio, Percutaneous Coronary Intervention, Myocardial Ischaemia
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
QFR Adoption Rate
Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.
Measured: At enrollment (baseline)
Secondary outcomes (6)
MACE
A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization
Measured: 6 month, 1 year, 3 years, and 5 years
Death
Cardiovascular, non-cardiovascular and undetermined death
Measured: 6 months, 1 year, 3 years, and 5 years
MI
Target vessel related and non-target vessel related MI
Measured: 6 months, 1 year, 3 years, and 5 years
Target vessel revascularization (TVR)
The ischemia driven and non-ischemia driven TVR
Measured: 6 months, 1 year, 3 years, and 5 years
Any coronary artery revascularization
The ischemia driven and non-ischemia driven Revascularization
Measured: 6 months, 1 year, 3 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: 6 months, 1 year, 3 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start26 Aug 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Guangdong Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Sir Run Run Shaw Hospital, Fuwai Huazhong Cardiovascular Hospital, Fuwai Yunnan Cardiovascular Hospital, Second Hospital of Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766434
- Sponsor's protocol ID
- 2025ZD0546701
- Acronym
- QFR-REAL
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 41263729Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
PubMed 39210710Xu 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 34742368Xu 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Real-World Registry of Quantitative Flow Ratio-Guided Coronary REvascularization and QuAlity evaLuation
- ClinicalTrials.gov ID
- NCT07766434
- Acronym / sponsor ID
- QFR-REAL / 2025ZD0546701
- Conditions
- Coronary Artery Disease
- Keywords
- Quantitative Coronary Angiography, Quantitative Flow Ratio, Percutaneous Coronary Intervention, Myocardial Ischaemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Guangdong Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, Sir Run Run Shaw Hospital, Fuwai Huazhong Cardiovascular Hospital, Fuwai Yunnan Cardiovascular Hospital, Second Hospital of Jilin University
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 Aug 2026 (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.
This prospective, multicenter observational registry aims to establish a QFR-based quality control standard system for coronary revascularization in patients with coronary artery disease. The study will enroll over 10,000 patients with visually estimated at least one main branch coronary stenosis ≥50% from more than 50 centers across China (covering provincial, municipal, and county-level hospitals). Coronary angiographic images and intracoronary imaging (if available) will be collected and retrospectively analyzed by an independent core laboratory. The primary endpoint is QFR acquisition accessibility, defined as the mean of QFR usage proportion across centers.
Detailed description
This is a prospective, multicenter, observational registry study conducted at more than 50 centers across China. Patients with coronary angiography showing visually estimated at least one main branch stenosis ≥50% who undergo PCI or receive conservative treatment for acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction >4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) will be consecutively enrolled. Coronary angiographic images will be submitted to an independent core laboratory for retrospective QFR analysis. The study will establish a QFR-based quality control standard system for coronary revascularization.
Prespecified subgroup analyses will be performed to assess the concordance rates, overtreatment, and undertreatment rates between clinical decisions and offline core laboratory QFR, and to explore heterogeneity across hospital levels, clinical presentations, disease complexity, target vessel, operator annual PCI volume, QFR image analyzability, and lesion morphology. Other prespecified subgroups will be analyzed for the primary and secondary endpoints, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% who present with asymptomatic ischemia, stable angina, unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction (>4 weeks after onset) and undergo PCI or receive conservative treatment at one of the participating centers.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Coronary angiography showing visually estimated at least one main branch coronary stenosis ≥50% in patients with acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction >4 weeks after onset) or chronic coronary syndrome (including stable angina and asymptomatic myocardial ischemia) who undergo PCI or receive conservative treatment
- Ability to understand the study design and provide written informed consent
Key exclusion criteria (6 listed)
- ST-segment elevation myocardial infarction within 4 weeks of onset
- History of coronary artery bypass grafting (CABG) or planned CABG within 6 months
- Inability to undergo coronary angiography
- Non-cardiac cause with expected survival <1 year
- Other conditions that may interfere with follow-up (e.g., dementia, substance abuse including drug addiction and other drug dependencies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QFR Adoption Rate
Time frame: At enrollment (baseline)
Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.
6 secondary outcomes
MACE
Time frame: 6 month, 1 year, 3 years, and 5 years
Death
Time frame: 6 months, 1 year, 3 years, and 5 years
MI
Time frame: 6 months, 1 year, 3 years, and 5 years
Target vessel revascularization (TVR)
Time frame: 6 months, 1 year, 3 years, and 5 years
Any coronary artery revascularization
Time frame: 6 months, 1 year, 3 years, and 5 years
Definite or probable stent thrombosis
Time frame: 6 months, 1 year, 3 years, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 41263729Zhang 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.
- Background: PubMed 39210710Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
- Background: 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.
- 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Qian, PhD (010-88396089, qianjfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QFR Adoption Rate (time frame: At enrollment (baseline)). 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 NCT07766434, which also lists 4 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 24 Sep 2026.