Coronary Artery DiseaseNCT06322355
Comparison of UFR With QFR in Stable Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasound
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The participants included in the study had at least one target lesion demonstrating 30% to 90% diameter stenosis, as visually estimated from CAG.
Who may be able to join
- Patients who underwent both IVUS imaging and FFR measurement on the same artery
Who cannot join
- Inadequate quality of CAG or IVUS images for QFR or UFR calculation
- Left main or ostial right coronary artery lesion
- The use of balloon predilatation or stent placement prior to FFR measurement or IVUS imaging
- Incomplete IVUS pullback across the entire lesion segment
- The presence of a severe myocardial bridge (defined as ≥30% systolic diameter stenosis) in the examined vessel
- History of previous coronary artery bypass grafting,
- Left ventricular ejection fraction <35%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Flow Ratio Derived From Intravascular Ultrasound With Coronary Angiography in Stable Coronary Artery Disease: Correlation With Fractional Flow Reserve
Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions.
Read the detailed description
Coronary artery disease (CAD) remains a prevalent global health concern, necessitating precise diagnostic strategies for optimal patient management. Fractional Flow Reserve (FFR), defined as the distal-to-proximal pressure ratio across a coronary stenosis during maximal hyperemia and typically measured by a pressure guidewire during coronary angiography (CAG), is considered a gold standard tool for detecting ischemia-causing stenosis and guiding revascularization decisions. However, wire-based FFR has been significantly underutilized due to practical reasons, including its invasive nature and the requirement for hyperemia. Consequently, there is growing interest in developing and validating computational FFR from anatomical information derived from CAG and intravascular imaging modalities, such as intravascular ultrasound (IVUS).
Quantitative flow reserve (QFR), derived from CAG, has been extensively investigated and has demonstrated high diagnostic performance for detecting hemodynamically significant lesions. Beyond CAG, research has indicated that IVUS imaging can also be utilized for computing FFR. IVUS, a widely accepted and powerful modality for evaluating vessel luminal size and characterizing plaque morphology in the context of coronary intervention, has given rise to IVUS-based FFR, known as ultrasonic flow ratio (UFR). UFR has been recently developed, integrating an estimation of physiology with intravascular imaging in the same IVUS pullback. Despite the proven effectiveness of both UFR and QFR, there is currently no evidence supporting the superiority of one technique over the other. In the present study, investigators aim to compare the diagnostic performance of UFR and QFR for the detection of functionally significant coronary lesions, using conventional FFR as the gold standard.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasound
- 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.
Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasoundDiagnostic test
Invasive CAG was conducted following standard clinical procedures, encompassing multiple projections of both the left and right coronary arteries. The FFR was precisely measured using either an intracoronary pressure wire (Pressure Wire X; Abbott Vascular, Santa Clara, USA) or a rapid-exchange pressure microcatheter (Insight Lifetech, Shanghai, China) during peak hyperemia. This state of maximal hyperemia was achieved through the intravenous infusion of adenosine triphosphate (ATP) at a concentration of 150 μg/kg/min, administered via the forearm vein. Upon completion of the FFR assessment, the pressure wire or microcatheter was carefully retracted to the tip of the guiding catheter for a routine drift check. IVUS imaging was meticulously conducted using the iLab™ IVUS system, coupled with a 40-MHz OptiCross IVUS catheter (Boston Scientific, Fremont, USA), at a steady pullback speed of 0.5 mm/s.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare diagnostic performance of QFR with UFR
Measured: baseline
Secondary outcomes (1)
Correlation and agreement between QFR and UFR
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jul 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322355
- Sponsor's protocol ID
- ZSUFR01
- Status last verified
- Mar 2024
- First submitted
- 15 Jan 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu R, Wang Z, Pan C, Gao W, Ma L, Wu Y, Chen Z, Lu Y, Dong Y, Yu W, Tu S, Li C, Ge J. Comparison of Flow Ratio Derived From IVUS With CAG in Complex Lesions: Correlation With FFR. JACC Asia. 2026 May;6(5):637-647. doi: 10.1016/j.jacasi.2025.12.019. Epub 2026 Feb 28.
PubMed 41762179
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Flow Ratio Derived From Intravascular Ultrasound With Coronary Angiography in Stable Coronary Artery Disease: Correlation With Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT06322355
- Acronym / sponsor ID
- ZSUFR01
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Mar 2024 (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.
Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions.
Detailed description
Coronary artery disease (CAD) remains a prevalent global health concern, necessitating precise diagnostic strategies for optimal patient management. Fractional Flow Reserve (FFR), defined as the distal-to-proximal pressure ratio across a coronary stenosis during maximal hyperemia and typically measured by a pressure guidewire during coronary angiography (CAG), is considered a gold standard tool for detecting ischemia-causing stenosis and guiding revascularization decisions. However, wire-based FFR has been significantly underutilized due to practical reasons, including its invasive nature and the requirement for hyperemia. Consequently, there is growing interest in developing and validating computational FFR from anatomical information derived from CAG and intravascular imaging modalities, such as intravascular ultrasound (IVUS).
Quantitative flow reserve (QFR), derived from CAG, has been extensively investigated and has demonstrated high diagnostic performance for detecting hemodynamically significant lesions. Beyond CAG, research has indicated that IVUS imaging can also be utilized for computing FFR. IVUS, a widely accepted and powerful modality for evaluating vessel luminal size and characterizing plaque morphology in the context of coronary intervention, has given rise to IVUS-based FFR, known as ultrasonic flow ratio (UFR). UFR has been recently developed, integrating an estimation of physiology with intravascular imaging in the same IVUS pullback. Despite the proven effectiveness of both UFR and QFR, there is currently no evidence supporting the superiority of one technique over the other. In the present study, investigators aim to compare the diagnostic performance of UFR and QFR for the detection of functionally significant coronary lesions, using conventional FFR as the gold standard.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants included in the study had at least one target lesion demonstrating 30% to 90% diameter stenosis, as visually estimated from CAG.
Key inclusion criteria (1 listed)
- Patients who underwent both IVUS imaging and FFR measurement on the same artery
Key exclusion criteria (7 listed)
- Inadequate quality of CAG or IVUS images for QFR or UFR calculation
- Left main or ostial right coronary artery lesion
- The use of balloon predilatation or stent placement prior to FFR measurement or IVUS imaging
- Incomplete IVUS pullback across the entire lesion segment
- The presence of a severe myocardial bridge (defined as ≥30% systolic diameter stenosis) in the examined vessel
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 |
|---|---|---|
| Coronary angiography, Fractional Flow Reserve measurement, Intravascular ultrasoundInvasive CAG was conducted following standard clinical procedures, encompassing multiple projections of both the left and right coronary arteries. The FFR was precisely measured using either an intracoronary pressure wire (Pressure Wire X; Abbott Vascular, Santa Clara, USA) or a rapid-exchange pressure microcatheter (Insight Lifetech, Shanghai, China) during peak hyperemia. This state of maximal hyperemia was achieved through the intravenous infusion of adenosine triphosphate (ATP) at a concentration of 150 μg/kg/min, administered via the forearm vein. Upon completion of the FFR assessment, the pressure wire or microcatheter was carefully retracted to the tip of the guiding catheter for a routine drift check. IVUS imaging was meticulously conducted using the iLab™ IVUS system, coupled with a 40-MHz OptiCross IVUS catheter (Boston Scientific, Fremont, USA), at a steady pullback speed of 0.5 mm/s. | Diagnostic test | – |
Primary outcome
Compare diagnostic performance of QFR with UFR
Time frame: baseline
1 secondary outcome
Correlation and agreement between QFR and UFR
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 41762179Xu R, Wang Z, Pan C, Gao W, Ma L, Wu Y, Chen Z, Lu Y, Dong Y, Yu W, Tu S, Li C, Ge J. Comparison of Flow Ratio Derived From IVUS With CAG in Complex Lesions: Correlation With FFR. JACC Asia. 2026 May;6(5):637-647. doi: 10.1016/j.jacasi.2025.12.019. Epub 2026 Feb 28.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare diagnostic performance of QFR with UFR (time frame: baseline). 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 NCT06322355, which also lists 1 linked publication.
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 21 Mar 2024.