NCT07308496

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,402 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-12-29
• Last updated: 2026-02-12