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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: CT-FFR guided strategy; Diagnostic test: QFR guided strategy

• Study Type: Interventional
• Enrollment (Estimated): 1402
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Zheng, MD, PhD; Phone Number: +86 88396051; Email: zhengzhe@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient-level inclusion criteria:

1. Adults aged ≥18 years.
2. Patients with stable angina, unstable angina, or post-myocardial infarction ≥72 hours.
3. 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:

1. Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
2. Suspected acute myocardial infarction (ECG or biomarkers indicating acute phase).
3. 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.
4. Severe valvular heart disease, aortic disease, or large ventricular aneurysm requiring surgery.
5. Atrial fibrillation or other severe cardiac arrhythmias.
6. Refusal or inability to sign informed consent.

Lesion-level exclusion criteria:

1. Poor-quality CCTA images that prevent CT-FFR analysis.
2. Severe coronary vessel tortuosity, overlapping segments, or other factors expected to cause poor-quality invasive angiography, hindering QFR measurement.
3. Combined with chronic total occlusion lesions.
4. The stenosis degree of the left main coronary artery was ≥50%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-FFR group; The decisions of invasive angiography and revascularization will be guided by CT-FFR.	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.
Active Comparator: QFR group; The decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Death from any cause during the follow-up period.	12 Months After Randomization
Cardiac death	Death due to myocardial infarction, heart failure, or other cardiac causes.	12 Months After Randomization
Myocardial infarction (MI)	Defined according to the Fourth Universal Definition of Myocardial Infarction.	12 Months After Randomization
Repeat revascularization	Any planned or unplanned revascularization of the target vessel or graft.	12 Months After Randomization
Rehospitalization	Any hospital readmission for cardiac causes, recurrent angina, or other medical reasons.	12 Months After Randomization
Rate of invasive coronary angiography avoidance	The proportion of patients who avoided invasive coronary angiography after CT-FFR-based evaluation without adverse clinical outcomes.	12 Months After Randomization
Revascularization rate	The proportion of patients undergoing any coronary revascularization (PCI or CABG).	12 Months After Randomization
Number of stents implanted or bypass grafts performed	to assess procedural extent and resource utilization	12 Months After Randomization
Rate of optimal medical therapy	The proportion of patients treated conservatively without revascularization.	12 Months After Randomization
PCI rate	The proportion of patients receiving percutaneous coronary intervention.	12 Months After Randomization
CABG rate	The proportion of patients undergoing coronary artery bypass grafting.	12 Months After Randomization
Total cost	Including outpatient and inpatient diagnostic and treatment expenses, index hospitalization cost.	12 Months After Randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: CT-derived fractional flow reserve; Angiography-derived quantitative flow ratio
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2025-2855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes