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

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

The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a "real world" left-main bifurcation population and as compared with a prespecified performance goal.

Inclusion Criteria:

• Patient has distal unprotected Left-Main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥50% requiring revascularization.
• Left-Main Medina classification 100, 110, 101, 011, 010, 111
• Clinical and anatomic eligibility for PCI as agreed by the local Heart Team including anatomic SYNTAX Score (<33).
• Distal left main reference vessel diameter ≥3.0 mm and ≤5.5 mm. All target lesions must be located in a native coronary artery.
• Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values
• Able to understand and provide informed consent and comply with all study procedures including follow-up

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.