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Coronary Artery DiseaseCONQUERNCT07308496

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

A study testing CT-FFR guided strategy and QFR guided strategy in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
CT-FFR guided strategy and QFR guided strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,402 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 1 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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%.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhe Zheng, MD, PhD contact

+86 88396051

zhengzhe@fuwai.com

About this study

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.

Being tested
CT-FFR guided strategy, QFR guided strategy
Keywords
CT-derived fractional flow reserve, Angiography-derived quantitative flow ratio
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-FFR guided strategyDiagnostic 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 strategyDiagnostic 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.

Study groups in NCT07308496
Study groupRoleWhat they receive
CT-FFR groupExperimentalThe decisions of invasive angiography and revascularization will be guided by CT-FFR.
Receives: Diagnostic Test: CT-FFR guided strategy
QFR groupActive comparatorThe decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR.
Receives: Diagnostic Test: QFR guided strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 Months Post-Procedural Follow-Up

Secondary outcomes (12)

  1. All-cause death

    Death from any cause during the follow-up period.

    Measured: 12 Months After Randomization

  2. Cardiac death

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

    Measured: 12 Months After Randomization

  3. Myocardial infarction (MI)

    Defined according to the Fourth Universal Definition of Myocardial Infarction.

    Measured: 12 Months After Randomization

  4. Repeat revascularization

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

    Measured: 12 Months After Randomization

  5. Rehospitalization

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

    Measured: 12 Months After Randomization

  6. Rate of invasive coronary angiography avoidance

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

    Measured: 12 Months After Randomization

  7. Revascularization rate

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

    Measured: 12 Months After Randomization

  8. Number of stents implanted or bypass grafts performed

    to assess procedural extent and resource utilization

    Measured: 12 Months After Randomization

  9. Rate of optimal medical therapy

    The proportion of patients treated conservatively without revascularization.

    Measured: 12 Months After Randomization

  10. PCI rate

    The proportion of patients receiving percutaneous coronary intervention.

    Measured: 12 Months After Randomization

  11. CABG rate

    The proportion of patients undergoing coronary artery bypass grafting.

    Measured: 12 Months After Randomization

  12. Total cost

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

    Measured: 12 Months After Randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,402 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07308496
Sponsor's protocol ID
2025-2855
Acronym
CONQUER
Status last verified
Dec 2025
First submitted
13 Dec 2025
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CT-FFR guided strategy and QFR guided strategy in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhe Zheng, MD, PhD (+86 88396051, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure (time frame: 12 Months Post-Procedural Follow-Up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07308496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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