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Clinical Trials in China / NCT07766434
Recruiting Observational

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

NCT07766434 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Observational
Started
2026-08-26
Last updated
2026-09-24

Condition(s) studied

Coronary Artery Disease

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • QFR Adoption Rate — At enrollment (baseline)
    Defined as the mean across participating centers of the proportion of patients undergoing QFR assessment among eligible patients at each center.

Trial sites (1)

FacilityCityRegionStatus
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 Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766434 on ClinicalTrials.gov ↗ ← All trials in China