µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

290 Participants
are grouped into 2 trial groups
Group A: Main stent before branch balloon
Group B: Main stent after branch balloon

Trial outcomes

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.

Time frame
Perioperative

Secondary outcomes

1

Diagnostic accuracy of µQFR in main branch

The effect of intravascular ultrasound (IVUS)-derived parameters on the diagnostic performance of µQFR in assessing ischemia in the main branch before and after stenting, using FFR as the gold standard.

Time frame
Perioperative

Other outcomes

Sponsors and contacts

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