Clinical trial Recruiting at 1 site Observational Ages 18 and up

QFR-Guided Heart Revascularization Quality Registry in CAD

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

Run by China National Center for Cardiovascular Diseases · NCT07766434 · Data updated 2026-11-12

This registry tests whether using quantitative flow ratio (QFR) to guide coronary revascularization decisions across many centers can standardize quality in patients with coronary artery disease.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment10000 (estimated)
SponsorChina National Center for Cardiovascular Diseases
Government
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedAugust 26, 2026
Main results expectedJuly 2028
Study endsJuly 2029
Registry record updatedSeptember 24, 2026
Trial IDNCT07766434 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years and older with visually estimated ≥50% stenosis in a main coronary branch undergoing PCI or conservative management for acute or chronic coronary syndrome.

Probably not a fit

Patients with recent ST-elevation MI within 4 weeks, prior CABG planned within 6 months, or inability to undergo coronary angiography may have limited applicability or benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational registry enrolling over 10,000 patients from more than 50 centers in China who have at least one main-branch coronary stenosis of 50% or more. Images from coronary angiography, and intracoronary imaging if available, will be collected and analyzed retrospectively by an independent core laboratory to establish a QFR-based quality control standard for revascularization. Subgroup analyses will explore how concordance between clinical decisions and QFR results varies by hospital level, presentation, disease complexity, lesion characteristics, operator volume, and image quality. The primary endpoint is the accessibility of QFR, represented by the mean usage proportion across centers. The study will include adults with acute or chronic coronary syndromes and will follow participants as per observational registry norms.

Why it matters

Potential benefit: If successful, the registry could enable more consistent, QFR-guided decision-making to improve revascularization quality and patient outcomes.

How similar studies have gone: Previous work in image-based and QFR-guided assessments suggests potential for improving decision quality, though this exact large-scale, multicenter registry is novel in scope.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 informed consent

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

Where it's running

  • 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, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.