Cardiovascular DiseasesNCT07020195

QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease

A study testing Traditional SYNTAX scoring and QFR-Based Functional SYNTAX Score System in people with Cardiovascular Diseases, run by First Affiliated Hospital of Harbin Medical University.

Not yet recruiting

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiovascular Diseases
What is being tested?: Traditional SYNTAX scoring and QFR-Based Functional SYNTAX Score System
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,200 participants
Where: No sites listed yet
Study dates: 1 Jan 2026to 31 Dec 2029
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

Who may be able to join

Age ≥ 18 years old;
Diagnosed as MVD patient by coronary angiography (≥ 50% stenosis in ≥ 2 major vessels);
Plan to undergo PCI or CABG treatment, and ensure that the contrast images meet the imaging quality requirements for QFR analysis;
Voluntarily sign the informed consent form, be able to participate in randomization and cooperate in completing all follow-up visits.

Who cannot join

Acute myocardial infarction requires emergency PCI;
Severe left ventricular dysfunction (LVEF<30%) or cardiogenic shock;
The quality of coronary angiography images is poor, such as vascular overlap, respiratory artifacts, projection angles less than 25 °, or frame rates less than 15 frames per second;
Failure of QFR analysis due to severe calcified lesions (determined by the central laboratory);
eGFR<30 mL/min/1.73m ² or contrast agent allergy;
Patients using intravenous pressors, intra aortic balloon counterpulsation, or other mechanical circulatory support devices;

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Patients undergoing tracheal intubation treatment;
Patients who have received thrombolytic therapy before admission;
Pregnant women;
Expected survival time<1 year due to non cardiac reasons;
Patients who are not expected to receive antiplatelet therapy for at least 6 months;
Patients who have received CABG treatment in the past or plan to receive CABG treatment;
Patients who plan to undergo any surgical procedure within 6 months;
There are other conditions that may interfere with follow-up, such as dementia, drug abuse including drug use and drug dependence for other reasons.

About this study

Official title: QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease: A Prospective Multicenter Randomized Controlled Trial

The revascularization treatment of multi vessel coronary artery disease (MVD) has always been a complex and important field in the treatment of coronary heart disease. The relative benefits of PCI and CABG vascular reconstruction strategies have always been a controversial topic in the field of MVD treatment. At present, SYNTAX score is the most commonly used imaging scoring system in clinical practice for quantitatively evaluating the complexity of coronary artery MVD, preliminary selection of revascularization strategies, and risk stratification. However, the SYNTAX score is entirely based on anatomical information of the lesion, and the assessment of the degree of coronary artery ischemia caused by the lesion is not accurate enough. Relying solely on anatomical structures for scoring may overestimate the harm of non ischemic lesions. The functional SYNTAX score (FSS) combines functional assessment of coronary artery lesions with anatomical structure scoring, only including lesions with hemodynamic significance, effectively optimizing the traditional SYNTAX scoring system. Compared with traditional SYNTAX scoring, FSS can reduce the number of high-risk patients, objectively evaluate the functional significance of lesions, and guide PCI treatment, significantly improving clinical prognosis.

Quantitative flow ratio (QFR) is a novel method for evaluating the functional significance of coronary artery stenosis. However, it is currently unclear whether FSS based on QFR can achieve objective and accurate risk stratification, guide the selection of revascularization strategies, and improve the long-term prognosis of patients with coronary artery MVD. Higher quality prospective clinical trials need to be designed for verification.

Therefore, this study will use a functional SYNTAX scoring system based on QFR (QFR-FSS) to conduct a prospective, multicenter, randomized controlled clinical trial to evaluate the guiding value of QFR-FSS in selecting revascularization strategies for patients with coronary artery MVD and its impact on long-term cardiovascular prognosis.

Conditions: Cardiovascular Diseases
Being tested: Traditional SYNTAX scoring, QFR-Based Functional SYNTAX Score System
Keywords: Multivessel Disease, QFR-Based Functional SYNTAX Score System
Medical subject headings: Cardiovascular Diseases

What participants receive

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

Traditional SYNTAX scoringProcedure or surgery
Using traditional SYNTAX scoring to guide the selection of revascularization strategies
QFR-Based Functional SYNTAX Score SystemProcedure or surgery
Using QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies

Study groups in NCT07020195
Study group	Role	What they receive
Traditional SYNTAX scoring (SS)	Active comparator	Using traditional SYNTAX scoring to guide the selection of revascularization strategies Receives: Procedure: Traditional SYNTAX scoring
QFR-Based Functional SYNTAX Score System (QFR-FSS)	Experimental	Using QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies Receives: Procedure: QFR-Based Functional SYNTAX Score System

What is being measured

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

The incidence of major adverse cardiovascular events (MACE)
The incidence of major adverse cardiovascular events (MACE) 2 years after PCI or CABG surgery, defined as the composite endpoint of all-cause mortality, myocardial infarction, and ischemia driven revascularization.
Measured: 2 years

Secondary outcomes (7)

Composite endpoint of cardiogenic death and myocardial infarction
Composite endpoint of cardiogenic death and myocardial infarction
Measured: 2 years
Disease success rate
Disease success rate: including lesion success evaluated by contrast imaging (evaluated by the central laboratory, with a visual residual stenosis degree of less than 30% and TIMI blood flow grade 3 for lesions treated with stent implantation); The residual stenosis degree of lesions treated with balloon dilation is less than 50% visually, TIMI blood flow grade 3, and the functional evaluation of lesions is successful (evaluated by the central laboratory, QFR ≥ 0.80 immediately after surgery).
Measured: 2 years
Clinical success rate
Clinical success rate: On the basis of successful imaging lesions at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery, the incidence of MACE within the same hospitalization period (up to 7 days).
Measured: 2 years
The incidence of myocardial infarction
The incidence of myocardial infarction at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery, including perioperative myocardial infarction (SCAI definition) and spontaneous myocardial infarction.
Measured: 2 years
The incidence of all revascularization
The incidence of all revascularization (ischemia driven, non ischemia driven revascularization; infarct related artery, non infarct related artery revascularization, culprit and non culprit lesion revascularization) at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery.
Measured: 2 years
The incidence of confirmed and possible stent thrombosis
The incidence of confirmed and possible stent thrombosis (ARC-2 definition) at 30 days, 1 month, 6 months, 1 year, and 2 years after surgery (including stent thrombosis within the time range of acute, subacute, late, and late onset).
Measured: 2 year
Postoperative quality of life scores
Postoperative quality of life scores at 2 years (EQ-5D Scale).
Measured: 2 year

Timeline

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

1 Jan 202631 Dec 2029

First posted13 Jun 2025
Study start1 Jan 2026 (estimated)
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07020195
Sponsor's protocol ID: QFR-FSS
Status last verified: Jun 2025
First submitted: 26 May 2025
Last updated: 13 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QFR-Based Functional SYNTAX Score System in Optimizing Revascularization Strategy for Multivessel Disease: A Prospective Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07020195
Acronym / sponsor ID: QFR-FSS
Conditions: Cardiovascular Diseases
Keywords: Multivessel Disease, QFR-Based Functional SYNTAX Score System
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 1,200 participants (estimated)
Lead sponsor: First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
Study start: 1 Jan 2026 (estimated)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 13 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Traditional SYNTAX scoring (SS)	Active comparator	Procedure: Traditional SYNTAX scoringUsing traditional SYNTAX scoring to guide the selection of revascularization strategies
QFR-Based Functional SYNTAX Score System (QFR-FSS)	Experimental	Procedure: QFR-Based Functional SYNTAX Score SystemUsing QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 18 years old;
Diagnosed as MVD patient by coronary angiography (≥ 50% stenosis in ≥ 2 major vessels);
Plan to undergo PCI or CABG treatment, and ensure that the contrast images meet the imaging quality requirements for QFR analysis;
Voluntarily sign the informed consent form, be able to participate in randomization and cooperate in completing all follow-up visits.

Key exclusion criteria (14 listed)

Acute myocardial infarction requires emergency PCI;
Severe left ventricular dysfunction (LVEF<30%) or cardiogenic shock;
The quality of coronary angiography images is poor, such as vascular overlap, respiratory artifacts, projection angles less than 25 °, or frame rates less than 15 frames per second;
Failure of QFR analysis due to severe calcified lesions (determined by the central laboratory);
eGFR<30 mL/min/1.73m ² or contrast agent allergy;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Traditional SYNTAX scoringUsing traditional SYNTAX scoring to guide the selection of revascularization strategies	Procedure or surgery	Traditional SYNTAX scoring (SS)
QFR-Based Functional SYNTAX Score SystemUsing QFR-Based Functional SYNTAX Score System to guide the selection of revascularization strategies	Procedure or surgery	QFR-Based Functional SYNTAX Score System (QFR-FSS)

Primary outcome

The incidence of major adverse cardiovascular events (MACE)
Time frame: 2 years
The incidence of major adverse cardiovascular events (MACE) 2 years after PCI or CABG surgery, defined as the composite endpoint of all-cause mortality, myocardial infarction, and ischemia driven revascularization.

7 secondary outcomes

Composite endpoint of cardiogenic death and myocardial infarction
Time frame: 2 years
Disease success rate
Time frame: 2 years
Clinical success rate
Time frame: 2 years
The incidence of myocardial infarction
Time frame: 2 years
The incidence of all revascularization
Time frame: 2 years
The incidence of confirmed and possible stent thrombosis
Time frame: 2 year
Postoperative quality of life scores
Time frame: 2 year

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Traditional SYNTAX scoring and QFR-Based Functional SYNTAX Score System in people with Cardiovascular Diseases, run by First Affiliated Hospital of Harbin Medical University.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. 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 13 Jun 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of major adverse cardiovascular events (MACE) (time frame: 2 years). 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 NCT07020195.

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 13 Jun 2025.