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

Recruitingn/aAges 18 Years - anyAllChina National Center for Cardiovascular Diseases
NCT07766434 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
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, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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