Trial Parameters
Brief Summary
This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter \>2.0 (visual estimation) and with a clinical indication to PCI, will be enrolled. After successful predilatation (with any tool deemed useful), patients will be randomized 1:1:1 to SCB, PCB or standard treatment with DES for bifurcation native vessel disease. All patients with a clinical indication for PCI, both stable coronary artery disease and acute coronary syndrome, will be enrolled. Before participating all the candidates will be clearly informed about the study, including the possible risks and benefits, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria, or that may have at least one exclusion criteria, and then be excluded from the study (screening failure), even after informed consent is obtained. Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria, will participate to the study. After randomization, the procedure will consist in standard coronary angioplasty following international guidelines/consensus documents and as per local practice. If the patient has been randomized to SCB or PCB, it is mandatory to adequately prepare the lesion.
Eligibility Criteria
Inclusion Criteria: * Subject must be age ≥18 years. * Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. * Subject understands the trial design and treatment procedures and provides written informal consent before entering the trial * Subject is willing to comply with all protocol-required follow-up evaluations. * Target lesion must be native non-LM bifurcation lesion * Target lesion must be a bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, Medina 1,1,1 or Medina 0,0,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI). * Target lesion reference vessel diameter (both main vessel and side branch) * 2.0 mm by visual estimation. * Target lesion must have visually estimated stenosis ≥50%. * Target lesion length of side branch must be \<25 mm by visual estimation. Exclusion Criteria: * Patient with STEMI (within 3 days from the onset of ch