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

European Cardiovascular Research Institute (ECRI)

Status: Terminated

Conditions: Coronary Stenosis

Treatments: Device: BiOSS LIM C

Study type: Interventional

Funder types: Industry

Identifiers

NCT03508219

ECRI-010

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

BiOSS LIM C

Experimental group

Description:

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.

Treatment:

Device: BiOSS LIM C