An interventional study of Traditional SYNTAX scoring and QFR-Based Functional SYNTAX Score System in Cardiovascular Diseases, sponsored by First Affiliated Hospital of Harbin Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by First Affiliated Hospital of Harbin Medical University · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
Using traditional SYNTAX scoring to guide the selection of revascularization strategies
Procedure: Traditional SYNTAX scoring
Using QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies
Procedure: QFR-Based Functional SYNTAX Score System
Using traditional SYNTAX scoring to guide the selection of revascularization strategies
Using QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies
The incidence of major adverse cardiovascular events (MACE)
The incidence of major adverse cardiovascular events (MACE) 2 years after PCI or CABG surgery, defined as the composite endpoint of all-cause mortality, myocardial infarction, and ischemia driven revascularization.
Time frame: 2 years
Composite endpoint of cardiogenic death and myocardial infarction
Composite endpoint of cardiogenic death and myocardial infarction
Time frame: 2 years
Disease success rate
Disease success rate: including lesion success evaluated by contrast imaging (evaluated by the central laboratory, with a visual residual stenosis degree of less than 30% and TIMI blood flow grade 3 for lesions treated with stent implantation); The residual stenosis degree of lesions treated with balloon dilation is less than 50% visually, TIMI blood flow grade 3, and the functional evaluation of lesions is successful (evaluated by the central laboratory, QFR ≥ 0.80 immediately after surgery).
Time frame: 2 years
Clinical success rate
Clinical success rate: On the basis of successful imaging lesions at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery, the incidence of MACE within the same hospitalization period (up to 7 days).
Time frame: 2 years
The incidence of myocardial infarction
The incidence of myocardial infarction at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery, including perioperative myocardial infarction (SCAI definition) and spontaneous myocardial infarction.
Time frame: 2 years
The incidence of all revascularization
The incidence of all revascularization (ischemia driven, non ischemia driven revascularization; infarct related artery, non infarct related artery revascularization, culprit and non culprit lesion revascularization) at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery.
Time frame: 2 years
The incidence of confirmed and possible stent thrombosis
The incidence of confirmed and possible stent thrombosis (ARC-2 definition) at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery (including stent thrombosis within the time range of acute, subacute, late, and late onset).
Time frame: 2 year
Postoperative quality of life scores
Postoperative quality of life scores at 2 years (EQ-5D Scale).
Time frame: 2 year
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Harbin Medical University