ClinicalTrials.gg
RecruitingNCT07766434QFR-REALUpdated Sep 24, 2026

A Prospective Multicenter Real-World Registry of Quantitative Flow Ratio-Guided Coronary REvascularization and QuAlity evaLuation

An observational study in Coronary Artery Disease, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by China National Center for Cardiovascular Diseases · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases — 26 open to participants now, 27 under way, none of them phase 3. Coronary Artery Disease · China National Center for Cardiovascular Diseases.

Planned enrollment
Largest of 25
10,000 · median 460
Started
2026
with 10 others
Observational
25 of 57
9 open now
Primary completion
2028-07
later than 17 of 26 live
Registered
52nd of 57
by date

Among the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases, this one has the largest planned enrollment of the 25 observational ones that give a count, is one of 11 that started in 2026, is one of 25 observational ones, reaches primary completion later than 17 of the 26 other live ones, and was the 52nd registered.

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

26 of the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases are open now, in 1 country. Recruiting first, the newest first:

20 more — sign in →

By country, each count listing its studies:

All 26 open studies →

Where they have run

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Coronary Artery Disease

Keywords

  • Quantitative Coronary Angiography
  • Quantitative Flow Ratio
  • Percutaneous Coronary Intervention
  • Myocardial Ischaemia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. QFR Adoption Rate

    Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.

    Time frame: At enrollment (baseline)

Secondary outcomes

  1. MACE

    A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization

    Time frame: 6 month, 1 year, 3 years, and 5 years

  2. Death

    Cardiovascular, non-cardiovascular and undetermined death

    Time frame: 6 months, 1 year, 3 years, and 5 years

  3. MI

    Target vessel related and non-target vessel related MI

    Time frame: 6 months, 1 year, 3 years, and 5 years

  4. Target vessel revascularization (TVR)

    The ischemia driven and non-ischemia driven TVR

    Time frame: 6 months, 1 year, 3 years, and 5 years

  5. Any coronary artery revascularization

    The ischemia driven and non-ischemia driven Revascularization

    Time frame: 6 months, 1 year, 3 years, and 5 years

  6. 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

    Time frame: 6 months, 1 year, 3 years, and 5 years

07

Study locations

1 of 1 sites 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, China
    Recruiting
08

References and documents

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 41263729 ↗
  • Vrints 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 39210710 ↗
  • 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 ↗
  • 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 23 months is below that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2026
First posted
Aug 14, 2026
StartActual
Aug 26, 2026
Primary completionEst.
Jul 2028
CompletionEst.
Jul 2029
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07766434
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
First posted
Aug 14, 2026
Start date
Aug 26, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2029 (estimated)
Last update
Sep 24, 2026

Study contacts

Jie Qian, PhD
Contact
qianjfw@163.com
010-88396089

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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