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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Stenosis
• Intervention / Treatment: Device: BiOSS LIM C

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France
    • Research Centre FRA-001
  • Bron, France
    • Research Centre FRA-004
  • Grenoble, France
    • Research Centre FRA-003
  • Saint-Denis, France
    • Research Centre FRA-002
• Italy
  • Naples, Italy
    • Research Centre ITA-001
  • Ragusa, Italy
    • Research Centre ITA-002
  • Syracuse, Italy
    • Research Centre ITA-003
• Poland
  • Katowice, Poland
    • Research Centre PL-006
  • Krakow, Poland
    • Research Centre PL-007
  • Olsztyn, Poland
    • Research Centre PL-004
  • Poznan, Poland
    • Research Centre PL-005
  • Warsaw, Poland
    • Research Centre PL-001
  • Warsaw, Poland
    • Research Centre PL-008
  • Zabrze, Poland
    • Research Centre PL-002
  • Zabrze, Poland
    • Research Centre PL-003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BiOSS LIM C; 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; 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.; Other Names: ALEX Plus; XIENCE

What is the study measuring?

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. The safety and efficacy of the BiOSS LIM C® stent with respect to a PoCE at 12 months in a real world LM bifurcation population compared with a pre-specified performance goal was not confirmed. The POLBOS LM study showed that the BiOSS LIM C® stent was not non-inferior to the XIENCE stent for percutaneous treatment of the LM disease.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-oriented Composite Endpoint (PoCE)	PoCE is defined as a composite of all-cause death, stroke, any MI, and any revascularization	12 months
Target Vessel Failure	Target Vessel Failure is defined as the composite of cardiac death, target vessel MI, and clinically indicated target vessel revascularization	12 months
Target Lesion Failure	Target Lesion Failure is defined as a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization	12 months
Mortality	Occurrence of death of any cause	12 months
Stroke	Occurrence of stroke (with a modified Rankin Scale >=1)	12 months
Myocardial Infarction	Occurrence of myocardial infarction	12 months
Revascularization	Occurrence of any revascularization (percutaneous coronary intervention or coronary artery bypass grafting)	12 months
Stent Thrombosis	Occurrence of any stent thrombosis according to standard definitions provided by the Academic Research Consortium	12 months

Collaborators and Investigators

• Sponsor: ECRI bv
• Collaborators: Cardialysis BV; Balton Sp.zo.o.
• Investigators: Principal Investigator: Robert Gil, Prof., Central Clinical Hospital of the Ministry of Interior in Warsaw

Publications and helpful links

Helpful Links

• Rationale and design of the POLBOS LM study

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention (PCI); Coronary Artery Disease (CAD); Left Main Bifurcation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: ECRI-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No