NCT07116083

µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 290 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Coronary Artery Disease
• Coronary Artery Disease (Left Main)
• Obstructive Coronary Artery Disease
• Stent Implantation

Timeline

• Start date: 2025-08-13
• Primary completion: 2026-08-30
• Completion: 2026-10-31
• First posted: 2025-08-11
• Last updated: 2026-02-02

Locations

1 site across 1 country: China