µQFR to check side‑branch narrowing after a single stent in bifurcation coronary arteries

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

This study will test whether µQFR from a single angiographic view can correctly detect functionally important side‑branch narrowing after single‑stent treatment in adults with obstructive coronary artery disease involving bifurcations.

Quick facts

• Study type: Observational
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07116083 on ClinicalTrials.gov

What this trial studies

This observational study at Zhongshan Hospital, Fudan University will enroll adults with angiographically confirmed true coronary bifurcation lesions treated with a single‑stent strategy. Investigators will derive µQFR from single‑view angiography images after percutaneous coronary intervention and determine its diagnostic performance for side‑branch stenosis compared with routine physiological assessments. Eligible lesions must have a side branch diameter ≥2.5 mm and visually estimated stenosis ≥50%; patients with acute MI, cardiogenic shock, severe renal dysfunction, or contrast allergy are excluded. The goal is to clarify how reliably µQFR reflects side‑branch physiology in the altered hemodynamic environment created by bifurcation stenting.

Who should consider this trial

Good fit: Adults (≥18 years) with obstructive CAD undergoing coronary angiography who have true bifurcation lesions with a side branch ≥2.5 mm and visually estimated stenosis ≥50% and who receive a single‑stent treatment are ideal candidates.

Not a fit: Patients with acute myocardial infarction, cardiogenic shock or severe heart failure, significant renal impairment (eGFR <45 mL/min/1.73 m²), iodinated contrast allergy, or those requiring complex two‑stent bifurcation strategies are unlikely to benefit from these findings.

Why it matters

Potential benefit: If successful, µQFR could allow clinicians to noninvasively determine whether a side branch truly needs additional treatment after single‑stent bifurcation PCI, reducing the need for pressure wires and extra procedures.

How similar studies have performed: Previous work has validated µQFR for straightforward coronary lesions, but its accuracy in bifurcation side branches after stenting remains largely untested.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chenguang Li, MD, PhD

Conditions Coronary Artery Disease; Obstructive Coronary Artery Disease; Stent Implantation; Functional Flow Reserve; Quantitative Flow Ratio