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

August 25, 2025 updated by: ECRI bv
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-oriented Composite Endpoint (PoCE)
Time Frame: 12 months
PoCE is defined as a composite of all-cause death, stroke, any MI, and any revascularization
12 months
Target Vessel Failure
Time Frame: 12 months
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
Time Frame: 12 months
Target Lesion Failure is defined as a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization
12 months
Mortality
Time Frame: 12 months
Occurrence of death of any cause
12 months
Stroke
Time Frame: 12 months
Occurrence of stroke (with a modified Rankin Scale >=1)
12 months
Myocardial Infarction
Time Frame: 12 months
Occurrence of myocardial infarction
12 months
Revascularization
Time Frame: 12 months
Occurrence of any revascularization (percutaneous coronary intervention or coronary artery bypass grafting)
12 months
Stent Thrombosis
Time Frame: 12 months
Occurrence of any stent thrombosis according to standard definitions provided by the Academic Research Consortium
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ECRI bv

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardialysis BV
Balton Sp.zo.o.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Gil, Prof., Central Clinical Hospital of the Ministry of Interior in Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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