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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Stenosis

Intervention / Treatment
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* Device: BiOSS LIM C


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiOSS LIM C<br>The treatment strategy consists of contemporary PCI of the left-main bifurcation, using the BiOSS LIM C stent system, following diagnostic angiography demonstrating significant distal unprotected left main disease and local Heart Team discussion applying the anatomic SYNTAX Score. | Device: BiOSS LIM C<br>* The BiOSS LIM C (Bifurcation Optimization Stent System, Balton, Warsaw, Poland). The BiOSS LIM C is a dedicated bifurcation stent covered with a mixture of a biodegradable polymer and the antiproliferative substance sirolimus. BiOSS LIM C will be used for treatment of the Left-Main bifurcation, according to its instructions for use. The Alex-Plus cobaltchromium sirolimus eluting stent (Balton, Warsaw, Poland) will be used for treatment of distal left-main side branches according to its instructions for use (i.e. proximal segments of the left anterior descending and left circumflex arteries as well as the ramus intermedius if the latter vessel is part of a trifurcation). All other lesions (other than left-main bifurcations) will be treated with XIENCE family everolimus-eluting coronary stent systems.<br>* Other names: XIENCE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority comparison of Patient-oriented composite endpoint (PoCE) of BiOSS LIM C to a pre-specified objective performance goal (OPC). | POCE defined as a composite measure of: All-cause mortality, Stroke (Modified Ranking Scale (mRS) ≥1), Any Myocardial infarction (MI) (includes non target vessel territory), Any unplanned revascularization for ischemia (includes all target and nontarget vessels). OPC based on data collected in Excel-study | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POCE defined as composite of all-cause death, stroke, any MI, and any revascularization |  | 30 days; 6 months | 
| Target Vessel Failure defined as cardiac death, Target vessel MI, and clinically indicated target vessel revascularization |  | 30 days; 6 months; 12 months | 
| Target Lesion Failure (device oriented composite endpoint) defined as cardiac death, target vessel MI, and clinically indicated target lesion revascularization |  | 30 days; 6 months ; 12 months | 
| Mortality |  | 30 days; 6 months; 12 months | 
| Stroke |  | 30 days; 6 months; 12 months | 
| Myocardial infarction |  | 30 days; 6 months; 12 months | 
| Revascularization |  | 30 days; 6 months; 12 months | 
| Stent thrombosis according to Academic Research Consortium classification |  | 30 days; 6 months; 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Left Main Bifurcation