Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07116083

µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Chenguang l, MD, PhD

CONTACT

[email protected]

008602164041990

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Diagnostic accuracy of µQFR in main branch

    Time frame: Perioperative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenguang Li, MD, PhD

CONTACT

[email protected]

008664041990

Jinying Zhou, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Diagnostic Performance of µQFR for Residual Functional Stenosis in Bifurcation Lesions After Single-stenting Strategy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.