µQFR to check side‑branch narrowing after a single stent in bifurcation coronary arteries
Official title: Diagnostic Performance of µQFR for Residual Functional Stenosis in Bifurcation Lesions After Single-stenting Strategy
Run by Shanghai Zhongshan Hospital · NCT07116083 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 290 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 13, 2025 |
| Main results expected | August 30, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT07116083 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous work has validated µQFR for straightforward coronary lesions, but its accuracy in bifurcation side branches after stenting remains largely untested.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Chenguang Li, MD, PhD
- Email: li.chenguang@zs-hospital.sh.cn
- Phone: 008664041990
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.