POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)

Exclusion Criteria

• •Prior PCI of the left main bifurcation at any time prior to enrollment
• •Currently participating in another trial and not yet at its primary endpoint.
• •Prior PCI of any other (non left main bifurcation) coronary artery lesion within 6 months (\<6 months) prior to enrollment.
• •Left-Main Medina classification 001.
• •Any segment of the left main bifurcation (distal left main, ostial Left Anterior Descending Artery (LAD) or ostial Left Circumflex Artery (LCX) presenting with a chronic total occlusion, or containing a visible thrombus.
• •Excessive angulation of the left main bifurcation (i.e. an angulation \>90° between proximal LAD and proximal LCX)
• •Direct stenting of the left main bifurcation
• •Prior Coronary Artery Bypass Surgery (CABG) at any time prior to enrollment
• •Patient requiring or may require additional surgery (cardiac or non-cardiac) within one year
• •Ongoing myocardial infarction or recent myocardial infarction with cardiac biomarker levels still elevated.
• •Known renal insufficiency (e.g. serum creatinine \>2.5mg/dL, or creatinine clearance ≤30mL/min, or patient on dialysis).
• •Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor.
• •Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 12 months.
• •Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential).
• •Concurrent medical condition with a life expectancy of less than 12 months.
• •The patient is unwilling/not able to return for outpatient clinic at 12 month follow-up.
• •Currently participating in another trial and not yet at its primary endpoint.