Coronary Artery DiseaseNCT07116083
µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions
An observational study of Coronary Artery Disease and Coronary Artery Disease (Left Main), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Murray-law based single-view quantitative flow ratio (µQFR) has been recommended for guiding percutaneous coronary intervention (PCI) in selective patients. However, it's reliability has not been validated in bifurcation lesions which present complex anatomy and flluid conditions before and after PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Disease (Left Main), Obstructive Coronary Artery Disease
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2025to 31 Oct 2026
- Phase
- Observational
- 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
Study population: Patients with obstructive bifurcation lesions who intended to undergo single-stent treatment.
Who may be able to join
- Age ≥ 18 years and provision of written informed consent for biospecimen donation upon hospital admission.
- Clinical suspicion or diagnosis of CAD requiring coronary angiography and physiological assessment.
- Angiographically confirmed true bifurcation lesions, including but not limited to: left main-left anterior descending-left circumflex (LM-LAD-LCx), left anterior descending-diagonal (LAD-Dg), left circumflex-obtuse marginal (LCx-OM), and right coronary artery-posterior left ventricular-posterior descending artery (RCA-PLV-PDA).
- Bifurcation lesion vessel diameter ≥ 2.5 mm with visually estimated angiographic diameter stenosis ≥ 50%.
Who cannot join
- Acute myocardial infarction.
- Cardiogenic shock or severe heart failure (Killip class IV).
- Serum creatinine > 150 μmol/L or estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² calculated using the CKD-EPI formula.
- Known allergy to iodinated contrast media.
- History of coronary artery bypass graft surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jinying Zhou, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Chenguang l, MD, PhD, 008602164041990, zhou.jinying@zs-hospital.sh.cn
About this study
Official title: Diagnostic Performance of µQFR for Residual Functional Stenosis in Bifurcation Lesions After Single-stenting Strategy
Murray-law based single-view quantitative flow ratio (µQFR) has been recommended for guiding percutaneous coronary intervention (PCI) in selective patients. However, it's reliability has not been validated in bifurcation lesions which present complex anatomy and flluid conditions before and after PCI. The goal of this study is to investigate the diagnostic performance of µQFR in side branch after single-stent treatment for bifurcation lesions in patient with obstructive coronary artery diseases.
Read the detailed description
The Murray law-based quantitative flow ratio (µQFR), derived from single-view angiography, is an established computational method for non-invasive functional assessment of coronary stenoses. Its utility in guiding percutaneous coronary intervention (PCI) in selected patients with straightforward lesions is recognized. However, its diagnostic reliability remains unvalidated in the context of coronary bifurcation lesions. These lesions exhibit inherent geometric and hemodynamic complexity due to altered flow patterns and shear stress distribution, both pre- and post-intervention. This complexity is particularly pertinent to side branches following single-stent strategies. Significant alterations in the local hemodynamic environment occur after stent deployment in the main vessel, potentially impacting side branch physiology and the accuracy of µQFR calculations specifically within this branch. Consequently, an evidence gap persists regarding the performance of µQFR for functional evaluation of the side branch after bifurcation PCI. This study specifically aims to evaluate the diagnostic performance of µQFR for assessing the functional significance of side branch stenoses after single-stent treatment of bifurcation lesions in patients with obstructive coronary artery disease (CAD). The primary objective is to determine the diagnostic performance of post-procedural µQFR measurements within the side branch of such complex lesions. The second objective is to investigate potential factors influencing the diagnostic performance of µQFR.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (Left Main), Obstructive Coronary Artery Disease, Stent Implantation
- Keywords
- Functional Flow Reserve, 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.
| Study group | Role | What they receive |
|---|---|---|
| Main stent before branch balloon | Patiens is allocated pot-hoc to this group if the operator performs the single stent in the main branch first and follows with balloon expansion in the ostium of the side branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches. | |
| Main stent after branch balloon | Patiens is allocated pot-hoc to this group if the operator performs expend the ostium of the side branch and then plants the single stent in the main branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of µQFR in side branch
The diagnostic accuracy of µQFR in assessing ischemia in the side branch, using FFR as the gold standard, following main vessel stenting.
Measured: Perioperative
Secondary outcomes (1)
Diagnostic accuracy of µQFR in main branch
The effect of intravascular ultrasound (IVUS)-derived parameters on the diagnostic performance of µQFR in assessing ischemia in the main branch before and after stenting, using FFR as the gold standard.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start13 Aug 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
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
- NCT07116083
- Sponsor's protocol ID
- ZSCD2025-01
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing might be possible upon reasonable requirement and under institutional administrative regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of µQFR for Residual Functional Stenosis in Bifurcation Lesions After Single-stenting Strategy
- ClinicalTrials.gov ID
- NCT07116083
- Acronym / sponsor ID
- ZSCD2025-01
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (Left Main), Obstructive Coronary Artery Disease, Stent Implantation
- Keywords
- Functional Flow Reserve, Quantitative Flow Ratio
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Aug 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.
Murray-law based single-view quantitative flow ratio (µQFR) has been recommended for guiding percutaneous coronary intervention (PCI) in selective patients. However, it's reliability has not been validated in bifurcation lesions which present complex anatomy and flluid conditions before and after PCI. The goal of this study is to investigate the diagnostic performance of µQFR in side branch after single-stent treatment for bifurcation lesions in patient with obstructive coronary artery diseases.
Detailed description
The Murray law-based quantitative flow ratio (µQFR), derived from single-view angiography, is an established computational method for non-invasive functional assessment of coronary stenoses. Its utility in guiding percutaneous coronary intervention (PCI) in selected patients with straightforward lesions is recognized. However, its diagnostic reliability remains unvalidated in the context of coronary bifurcation lesions. These lesions exhibit inherent geometric and hemodynamic complexity due to altered flow patterns and shear stress distribution, both pre- and post-intervention. This complexity is particularly pertinent to side branches following single-stent strategies. Significant alterations in the local hemodynamic environment occur after stent deployment in the main vessel, potentially impacting side branch physiology and the accuracy of µQFR calculations specifically within this branch. Consequently, an evidence gap persists regarding the performance of µQFR for functional evaluation of the side branch after bifurcation PCI. This study specifically aims to evaluate the diagnostic performance of µQFR for assessing the functional significance of side branch stenoses after single-stent treatment of bifurcation lesions in patients with obstructive coronary artery disease (CAD). The primary objective is to determine the diagnostic performance of post-procedural µQFR measurements within the side branch of such complex lesions. The second objective is to investigate potential factors influencing the diagnostic performance of µQFR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main stent before branch balloon | – | –Patiens is allocated pot-hoc to this group if the operator performs the single stent in the main branch first and follows with balloon expansion in the ostium of the side branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches. |
| Main stent after branch balloon | – | –Patiens is allocated pot-hoc to this group if the operator performs expend the ostium of the side branch and then plants the single stent in the main branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obstructive bifurcation lesions who intended to undergo single-stent treatment.
Key inclusion criteria (4 listed)
- Age ≥ 18 years and provision of written informed consent for biospecimen donation upon hospital admission.
- Clinical suspicion or diagnosis of CAD requiring coronary angiography and physiological assessment.
- Angiographically confirmed true bifurcation lesions, including but not limited to: left main-left anterior descending-left circumflex (LM-LAD-LCx), left anterior descending-diagonal (LAD-Dg), left circumflex-obtuse marginal (LCx-OM), and right coronary artery-posterior left ventricular-posterior descending artery (RCA-PLV-PDA).
- Bifurcation lesion vessel diameter ≥ 2.5 mm with visually estimated angiographic diameter stenosis ≥ 50%.
Key exclusion criteria (5 listed)
- Acute myocardial infarction.
- Cardiogenic shock or severe heart failure (Killip class IV).
- Serum creatinine > 150 μmol/L or estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² calculated using the CKD-EPI formula.
- Known allergy to iodinated contrast media.
- History of coronary artery bypass graft surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of µQFR in side branch
Time frame: Perioperative
The diagnostic accuracy of µQFR in assessing ischemia in the side branch, using FFR as the gold standard, following main vessel stenting.
1 secondary outcome
Diagnostic accuracy of µQFR in main branch
Time frame: Perioperative
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 2 Feb 2026.
- Individual participant dataSharing planned: No. IPD sharing might be possible upon reasonable requirement and under institutional administrative regulations.
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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.
Jinying Zhou, MD, PhD contact
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 and Coronary Artery Disease (Left Main), 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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?
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 Chenguang Li, MD, PhD (008664041990, li.chenguang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of µQFR in side branch (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.