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Recruiting Observational

µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions

NCT07116083 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-08-13
Last updated
2026-02-02

Condition(s) studied

Coronary Artery DiseaseCoronary Artery Disease (Left Main)Obstructive Coronary Artery DiseaseStent Implantation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years and provision of written informed consent for biospecimen donation upon hospital admission. 2. Clinical suspicion or diagnosis of CAD requiring coronary angiography and physiological assessment. 3. 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). 4. Bifurcation lesion vessel diameter ≥ 2.5 mm with visually estimated angiographic diameter stenosis ≥ 50%. Exclusion Criteria: 1. Acute myocardial infarction. 2. Cardiogenic shock or severe heart failure (Killip class IV). 3. Serum creatinine \> 150 μmol/L or estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m² calculated using the CKD-EPI formula. 4. Known allergy to iodinated contrast media. 5. History of coronary artery bypass graft surgery.

Primary outcome measure(s)

  • Diagnostic accuracy of µQFR in side branch — Perioperative
    The diagnostic accuracy of µQFR in assessing ischemia in the side branch, using FFR as the gold standard, following main vessel stenting.

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07116083 on ClinicalTrials.gov ↗ ← All trials in China