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NCT05705362
Simple Crossover Versus Side Branch Opening in Patients With Non-Left Main Bifurcation Lesion
Conditions: Coronary Artery Disease
Sex: All
Ages: 19 Years – N/A
Phase: NA
Enrollment: 1000
Sponsor: Keimyung University Dongsan Medical Center
Summary
Hypothesis:Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure (TLF) in patients with angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion.A total of 1000 patients (500 per each group) with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion will be enrolled.
Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 1:1 ratio.
Stratified randomization according to participating center, clinical presentation (acute coronary syndrome or stable ischemic heart disease), and type of bifurcation lesions (true or non-true) will be performed.
Eligibility Criteria
Inclusion Criteria:(1) Subject must be at least 19 years of age(2) Patients with non-left main bifurcation lesion (SB diameter ≥2.3 mm)(3) Target lesions amenable for 1-stenting with provisional SB approach by operators' decision(4) Angiographically compromised SB (visual SB stenosis ≥50%) after provisional MV stentingExclusion Criteria:(1) Target lesions requiring elective 2-stenting technique by operators' decision (Observation Group 1)*(2) Patients who inevitably require SB intervention after MV stenting, as follows.
(Observation Group 2)*Reduced SB TIMI flow (≤2) after MV stentingSB dissection after MV stenting (≥ Type C)(3) Patients without SB compromise after MV stenting (visually SB stenosis <50%) (Observation Group 3)*(4) Cardiogenic shock (Killip class IV) at presentation(5) Patients with significant valvular heart disease or severe left ventricular systolic dysfunction (ejection fraction <35%)(6) Pregnancy or breast feeding(7) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)(8) Unwillingness or inability to comply with the procedures described in this protocol
Source: ClinicalTrials.gov (NCT05705362). StuddyBuddy aggregates publicly available trial information.