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Not yet recruiting NCT07308496

Computed Tomography-derived Fractional Flow Reserve vs. Angiographic Quantitative Flow Ratio in Management of Patients With Coronary Artery Disease

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CT-FFR guided strategy, QFR guided strategy.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test 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.
  • Diagnostic test 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.

Primary outcome measures

  • Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure [Time frame: 12 Months Post-Procedural Follow-Up]
Secondary outcome measures (12)
  • All-cause death [Time frame: 12 Months After Randomization]
  • Cardiac death [Time frame: 12 Months After Randomization]
  • Myocardial infarction (MI) [Time frame: 12 Months After Randomization]
  • Repeat revascularization [Time frame: 12 Months After Randomization]
  • Rehospitalization [Time frame: 12 Months After Randomization]
  • Rate of invasive coronary angiography avoidance [Time frame: 12 Months After Randomization]
  • Revascularization rate [Time frame: 12 Months After Randomization]
  • Number of stents implanted or bypass grafts performed [Time frame: 12 Months After Randomization]
  • Rate of optimal medical therapy [Time frame: 12 Months After Randomization]
  • PCI rate [Time frame: 12 Months After Randomization]
  • CABG rate [Time frame: 12 Months After Randomization]
  • Total cost [Time frame: 12 Months After Randomization]

Eligibility criteria

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%.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07308496 · 2025-2855

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗