µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions

NCT07116083 | Recruiting

• 1 other identifier: ZSCD2025-01
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Functional Flow Reserve; Quantitative Flow Ratio

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of µQFR in side branch

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

  Perioperative

Secondary Outcomes (1)

• Diagnostic accuracy of µQFR in main branch

  Perioperative

Study Arms (2)

Main stent before branch balloon

Patiens is allocated pot-hoc to this group if the operator performs the single stent in the main branch first and follows with balloon expansion in the ostium of the side branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches.

Main stent after branch balloon

Patiens is allocated pot-hoc to this group if the operator performs expend the ostium of the side branch and then plants the single stent in the main branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with obstructive bifurcation lesions who intended to undergo single-stent treatment.

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Chenguang Li, MD, PhD

CONTACT

008664041990; li.chenguang@zs-hospital.sh.cn

Jinying Zhou, MD, PhD

CONTACT

zhou.jinying@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Cardiology

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)