Computed Tomography-derived Fractional Flow Reserve vs. Angiographic Quantitative Flow Ratio in Management of Patients With Coronary Artery Disease
NCT ID: NCT07308496
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1402 participants
INTERVENTIONAL
2026-01-01
2028-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CT-FFR group
The decisions of invasive angiography and revascularization will be guided by CT-FFR.
CT-FFR guided strategy
Patients in this group will undergo CT-derived fractional flow reserve (CT-FFR) analysis. If the CT-FFR value is ≤0.80, patients will subsequently undergo invasive coronary angiography (ICA) and receive coronary revascularization. If the CT-FFR values of all vessels are \>0.80, patients will not undergo invasive angiography.
QFR group
The decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR.
QFR guided strategy
Patients in this group will undergo invasive coronary angiography (ICA) according to routine clinical indications. During the procedure, quantitative flow ratio (QFR) analysis will be performed. If the QFR value is ≤0.80, coronary revascularization will be performed. If the QFR value is \>0.80, coronary revascularization will be forwent.
Interventions
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CT-FFR guided strategy
Patients in this group will undergo CT-derived fractional flow reserve (CT-FFR) analysis. If the CT-FFR value is ≤0.80, patients will subsequently undergo invasive coronary angiography (ICA) and receive coronary revascularization. If the CT-FFR values of all vessels are \>0.80, patients will not undergo invasive angiography.
QFR guided strategy
Patients in this group will undergo invasive coronary angiography (ICA) according to routine clinical indications. During the procedure, quantitative flow ratio (QFR) analysis will be performed. If the QFR value is ≤0.80, coronary revascularization will be performed. If the QFR value is \>0.80, coronary revascularization will be forwent.
Eligibility Criteria
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Inclusion Criteria
2. Patients with stable angina, unstable angina, or post-myocardial infarction ≥72 hours.
3. Patients are able and willing to provide written informed consent.
(1) Coronary CT angiography (CCTA) shows at least one coronary artery with 70%-90% diameter stenosis and vessel diameter ≥2.5 mm.
Exclusion Criteria
2. Suspected acute myocardial infarction (ECG or biomarkers indicating acute phase).
3. Moderate to severe chronic kidney disease, defined as serum creatinine \>150 μmol/L or estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m².
4. Severe valvular heart disease, aortic disease, or large ventricular aneurysm requiring surgery.
5. Atrial fibrillation or other severe cardiac arrhythmias.
6. Refusal or inability to sign informed consent.
1. Poor-quality CCTA images that prevent CT-FFR analysis.
2. Severe coronary vessel tortuosity, overlapping segments, or other factors expected to cause poor-quality invasive angiography, hindering QFR measurement.
3. Combined with chronic total occlusion lesions.
18 Years
ALL
No
Sponsors
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Fuwai Yunnan Cardiovascular Hospital
OTHER
Central China Fuwai Hospital of Zhengzhou University
OTHER
Shenzhen Sun Yat-sen Cardiovascular Hospital
OTHER
Ruijin Hospital
OTHER
Nanjing First Hospital, Nanjing Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Central Contacts
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Other Identifiers
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2025-2855
Identifier Type: -
Identifier Source: org_study_id