NCT07308496Not yet recruiting
Computed Tomography-derived Fractional Flow Reserve vs. Angiographic Quantitative Flow Ratio in Management of Patients With Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1402 (estimated)
- First submitted
- 13 Dec 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT07308496
What you commit to
- Study type: Interventional
- Planned participants: 1402
- From 1 Mar 2026 to the primary completion date, 1 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patient-level 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.
- Lesion-level inclusion criteria:
- (1) Coronary CT angiography (CCTA) shows at least one coronary artery with 70%-90% diameter stenosis and vessel diameter ≥2.5 mm.
- Patient-level exclusion criteria:
- Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- Suspected acute myocardial infarction (ECG or biomarkers indicating acute phase).
- 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.
- Lesion-level exclusion criteria:
- 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.
- Combined with chronic total occlusion lesions.
- The stenosis degree of the left main coronary artery was ≥50%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.