Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-02 @ 6:38 AM
Study NCT ID:
NCT07020195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of major adverse cardiovascular events (MACE)', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Composite endpoint of cardiogenic death and myocardial infarction', 'timeFrame': '2 years', 'description': 'Composite endpoint of cardiogenic death and myocardial infarction'}, {'measure': 'Disease success rate', 'timeFrame': '2 years', 'description': '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).'}, {'measure': 'Clinical success rate', 'timeFrame': '2 years', 'description': '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).'}, {'measure': 'The incidence of myocardial infarction', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'The incidence of all revascularization', 'timeFrame': '2 years', 'description': '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.'}, {'measure': 'The incidence of confirmed and possible stent thrombosis', 'timeFrame': '2 year', 'description': '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).'}, {'measure': 'Postoperative quality of life scores', 'timeFrame': '2 year', 'description': 'Postoperative quality of life scores at 2 years (EQ-5D Scale).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multivessel Disease', 'QFR-Based Functional SYNTAX Score System'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': '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.\n\nQuantitative 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.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* Diagnosed as MVD patient by coronary angiography (≥ 50% stenosis in ≥ 2 major vessels);\n* Plan to undergo PCI or CABG treatment, and ensure that the contrast images meet the imaging quality requirements for QFR analysis;\n* Voluntarily sign the informed consent form, be able to participate in randomization and cooperate in completing all follow-up visits.\n\nExclusion Criteria:\n\n* Acute myocardial infarction requires emergency PCI;\n* Severe left ventricular dysfunction (LVEF\\<30%) or cardiogenic shock;\n* The quality of coronary angiography images is poor, such as vascular overlap, respiratory artifacts, projection angles less than 25 °, or frame rates less than 15 frames per second;\n* Failure of QFR analysis due to severe calcified lesions (determined by the central laboratory);\n* eGFR\\<30 mL/min/1.73m ² or contrast agent allergy;\n* Patients using intravenous pressors, intra aortic balloon counterpulsation, or other mechanical circulatory support devices;\n* Patients undergoing tracheal intubation treatment;\n* Patients who have received thrombolytic therapy before admission;\n* Pregnant women;\n* Expected survival time\\<1 year due to non cardiac reasons;\n* Patients who are not expected to receive antiplatelet therapy for at least 6 months;\n* Patients who have received CABG treatment in the past or plan to receive CABG treatment;\n* Patients who plan to undergo any surgical procedure within 6 months;\n* There are other conditions that may interfere with follow-up, such as dementia, drug abuse including drug use and drug dependence for other reasons.'}, 'identificationModule': {'nctId': 'NCT07020195', 'briefTitle': 'QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease: A Prospective Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'QFR-FSS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional SYNTAX scoring (SS)', 'description': 'Using traditional SYNTAX scoring to guide the selection of revascularization strategies', 'interventionNames': ['Procedure: Traditional SYNTAX scoring']}, {'type': 'EXPERIMENTAL', 'label': 'QFR-Based Functional SYNTAX Score System (QFR-FSS)', 'description': 'Using QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies', 'interventionNames': ['Procedure: QFR-Based Functional SYNTAX Score System']}], 'interventions': [{'name': 'Traditional SYNTAX scoring', 'type': 'PROCEDURE', 'description': 'Using traditional SYNTAX scoring to guide the selection of revascularization strategies', 'armGroupLabels': ['Traditional SYNTAX scoring (SS)']}, {'name': 'QFR-Based Functional SYNTAX Score System', 'type': 'PROCEDURE', 'description': 'Using QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies', 'armGroupLabels': ['QFR-Based Functional SYNTAX Score System (QFR-FSS)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}