NCT07020195

QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease

QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease: A Prospective Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: First Affiliated Hospital of Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The revascularization treatment of multi vessel coronary artery disease (MVD) has always been a complex and important field in the treatment of coronary heart disease. The relative benefits of PCI and CABG vascular reconstruction strategies have always been a controversial topic in the field of MVD treatment. At present, SYNTAX score is the most commonly used imaging scoring system in clinical practice for quantitatively evaluating the complexity of coronary artery MVD, preliminary selection of revascularization strategies, and risk stratification. However, the SYNTAX score is entirely based on anatomical information of the lesion, and the assessment of the degree of coronary artery ischemia caused by the lesion is not accurate enough. Relying solely on anatomical structures for scoring may overestimate the harm of non ischemic lesions. The functional SYNTAX score (FSS) combines functional assessment of coronary artery lesions with anatomical structure scoring, only including lesions with hemodynamic significance, effectively optimizing the traditional SYNTAX scoring system. Compared with traditional SYNTAX scoring, FSS can reduce the number of high-risk patients, objectively evaluate the functional significance of lesions, and guide PCI treatment, significantly improving clinical prognosis. Quantitative flow ratio (QFR) is a novel method for evaluating the functional significance of coronary artery stenosis. However, it is currently unclear whether FSS based on QFR can achieve objective and accurate risk stratification, guide the selection of revascularization strategies, and improve the long-term prognosis of patients with coronary artery MVD. Higher quality prospective clinical trials need to be designed for verification. Therefore, this study will use a functional SYNTAX scoring system based on QFR (QFR-FSS) to conduct a prospective, multicenter, randomized controlled clinical trial to evaluate the guiding value of QFR-FSS in selecting revascularization strategies for patients with coronary artery MVD and its impact on long-term cardiovascular prognosis.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
PROCEDURE	Traditional SYNTAX scoring	Using traditional SYNTAX scoring to guide the selection of revascularization strategies
PROCEDURE	QFR-Based Functional SYNTAX Score System	Using QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-06-13
• Last updated: 2025-06-13