Computed Tomography-derived Fractional Flow Reserve vs. Angiographic Quantitative Flow Ratio in M… (NCT07308496) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Computed Tomography-derived Fractional Flow Reserve vs. Angiographic Quantitative Flow Ratio in Management of Patients With Coronary Artery Disease
1,402 participantsStarted 2026-03-01
Plain-language summary
This is a multi-center, randomized controlled trial to compare the clinical outcomes between CT-derived fractional flow reserve (CT-FFR) guided strategy and angiography-derived quantitative flow ratio (QFR) guided strategy among patients with coronary artery disease (CAD). Participants who have at least one coronary stenosis of 70%-90% (vessel diameter ≥2.5 mm) detected by coronary CT angiography will be enrolled and are randomly assigned in a 1:1 ratio to CT-FFR guided group or QFR guided group. In CT-FFR group, the decisions of invasive angiography and revascularization will be guided by CT-FFR. In QFR group, the decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR. The primary endpoint is the 1-year incidence of major adverse cardiac events (MACEs), including death, myocardial infarction, and unplanned revascularization.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults aged ≥18 years.
✓. Patients with stable angina, unstable angina, or post-myocardial infarction ≥72 hours.
✓. Patients are able and willing to provide written informed consent.
✕. 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.
✕. Severe valvular heart disease, aortic disease, or large ventricular aneurysm requiring surgery.
✕. Atrial fibrillation or other severe cardiac arrhythmias.
✕. Refusal or inability to sign informed consent.
✕
What they're measuring
1
Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure
Timeframe: 12 Months Post-Procedural Follow-Up
Trial details
NCT IDNCT07308496
SponsorChina National Center for Cardiovascular Diseases
. Poor-quality CCTA images that prevent CT-FFR analysis.
✕. Severe coronary vessel tortuosity, overlapping segments, or other factors expected to cause poor-quality invasive angiography, hindering QFR measurement.