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

NCT07308496 | Not Yet Recruiting

• 1 other identifier: 2025-2855
• Study Type: interventional
• Target: 1,402
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

CT-derived fractional flow reserve; Angiography-derived quantitative flow ratio

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure

  MACEs is defined as a composite of all-cause death, myocardial infarction, and unplanned revascularization.

  12 Months Post-Procedural Follow-Up

Secondary Outcomes (12)

• All-cause death

  12 Months After Randomization

• Cardiac death

  12 Months After Randomization

• Myocardial infarction (MI)

  12 Months After Randomization

• Repeat revascularization

  12 Months After Randomization

• Rehospitalization

  12 Months After Randomization

Study Arms (2)

CT-FFR group

EXPERIMENTAL

The decisions of invasive angiography and revascularization will be guided by CT-FFR.

Diagnostic Test: CT-FFR guided strategy

QFR group

ACTIVE COMPARATOR

The decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR.

Diagnostic Test: QFR guided strategy

Interventions

CT-FFR guided strategy DIAGNOSTIC_TEST

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.

CT-FFR group

QFR guided strategy DIAGNOSTIC_TEST

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.

QFR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• (1) Coronary CT angiography (CCTA) shows at least one coronary artery with 70%-90% diameter stenosis and vessel diameter ≥2.5 mm.

You may not qualify if:

• 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.
• 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%.

Sponsors & Collaborators

• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Central China Fuwai Hospital of Zhengzhou University: collaborator
• Shenzhen Sun Yat-sen Cardiovascular Hospital: collaborator
• Ruijin Hospital: collaborator
• Nanjing First Hospital, Nanjing Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• China National Center for Cardiovascular Diseases: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Zhe Zheng, MD, PhD

CONTACT

+86 88396051; zhengzhe@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share