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NCT Number: NCT07308496

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 12 Months Post-Procedural Follow-Up

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

Secondary outcomes

  1. All-cause death

    Time frame: 12 Months After Randomization

    Death from any cause during the follow-up period.

  2. Cardiac death

    Time frame: 12 Months After Randomization

    Death due to myocardial infarction, heart failure, or other cardiac causes.

  3. Myocardial infarction (MI)

    Time frame: 12 Months After Randomization

    Defined according to the Fourth Universal Definition of Myocardial Infarction.

  4. Repeat revascularization

    Time frame: 12 Months After Randomization

    Any planned or unplanned revascularization of the target vessel or graft.

  5. Rehospitalization

    Time frame: 12 Months After Randomization

    Any hospital readmission for cardiac causes, recurrent angina, or other medical reasons.

  6. Rate of invasive coronary angiography avoidance

    Time frame: 12 Months After Randomization

    The proportion of patients who avoided invasive coronary angiography after CT-FFR-based evaluation without adverse clinical outcomes.

  7. Revascularization rate

    Time frame: 12 Months After Randomization

    The proportion of patients undergoing any coronary revascularization (PCI or CABG).

  8. Number of stents implanted or bypass grafts performed

    Time frame: 12 Months After Randomization

    to assess procedural extent and resource utilization

  9. Rate of optimal medical therapy

    Time frame: 12 Months After Randomization

    The proportion of patients treated conservatively without revascularization.

  10. PCI rate

    Time frame: 12 Months After Randomization

    The proportion of patients receiving percutaneous coronary intervention.

  11. CABG rate

    Time frame: 12 Months After Randomization

    The proportion of patients undergoing coronary artery bypass grafting.

  12. Total cost

    Time frame: 12 Months After Randomization

    Including outpatient and inpatient diagnostic and treatment expenses, index hospitalization cost.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Zheng, MD, PhD

CONTACT

[email protected]

+86 88396051

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

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

Registry information

Acronym: CONQUER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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