About this trial
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
Qualifiers
(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 stenting
Disqualifiers
(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 stenting
SB dissection after MV stenting (≥ Type C)
Trial design
Treatments tested in this trial
- Simple Crossover
- Side branch opening