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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

China National Center for Cardiovascular Diseases

Lead sponsor

Guangdong Provincial People's Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Fuwai Huazhong Cardiovascular Hospital

Collaborator

Fuwai Yunnan Cardiovascular Hospital

Collaborator

Second Hospital of Jilin University

Collaborator