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

NCT03508219 | Terminated Results DMC

• 1 other identifier: ECRI-010
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 15

Brief Summary

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.

Conditions

Coronary Stenosis

Keywords

Coronary Artery Disease (CAD); Percutaneous Coronary Intervention (PCI); Left Main Bifurcation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Patient-oriented Composite Endpoint (PoCE)

  12 months

• Target Vessel Failure

  12 months

• Target Lesion Failure

  12 months

• Mortality

  12 months

• Stroke

  12 months

Study Arms (1)

BiOSS LIM C

EXPERIMENTAL

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

Interventions

BiOSS LIM C DEVICE

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.

Also known as: ALEX Plus, XIENCE

BiOSS LIM C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ECRI bv: lead
• Cardialysis BV: collaborator
• Balton Sp.zo.o.: collaborator

Study Sites (15)

Research Centre FRA-001

Aix-en-Provence, France

Location

Research Centre FRA-004

Bron, France

Location

Research Centre FRA-003

Grenoble, France

Location

Research Centre FRA-002

Saint-Denis, France

Location

Research Centre ITA-001

Naples, Italy

Location

Research Centre ITA-002

Ragusa, Italy

Location

Research Centre ITA-003

Syracuse, Italy

Location

Research Centre PL-006

Katowice, Poland

Location

Research Centre PL-007

Krakow, Poland

Location

Research Centre PL-004

Olsztyn, Poland

Location

Research Centre PL-005

Poznan, Poland

Location

Research Centre PL-001

Warsaw, Poland

Location

Research Centre PL-008

Warsaw, Poland

Location

Research Centre PL-002

Zabrze, Poland

Location

Research Centre PL-003

Zabrze, Poland

Location

Related Links

• Rationale and design of the POLBOS LM study

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Limitations and Caveats

The original sample was intended at 260 but the study only enrolled 130 participants since it was terminated prematurely due to COVID-19, safety concerns, and discontinuation of financial support.

Results Point of Contact

• Title: Ernest Spitzer, MD
• Organization: European Cardiovascular Research Institute (ECRI-10)

e.spitzer@ecri-trials.com

0031102062828

Study Officials

• Robert Gil, Prof.

  Central Clinical Hospital of the Ministry of Interior in Warsaw

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: August 10, 2018
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); PL (8); FR (4)