Coronary StenosisPOLBOS-LMNCT03508219
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
A study testing BiOSS LIM C in people with Coronary Stenosis, run by ECRI bv at 15 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- BiOSS LIM C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 10 Aug 2018to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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 locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Poland8 sites
Research Centre PL-006
Katowice
Research Centre PL-007
Krakow
Research Centre PL-004
Olsztyn
Research Centre PL-005
Poznan
Research Centre PL-001
Warsaw
Research Centre PL-008
Warsaw
Research Centre PL-002
Zabrze
Research Centre PL-003
Zabrze
France4 sites
Research Centre FRA-001
Aix-en-Provence
Research Centre FRA-004
Bron
Research Centre FRA-003
Grenoble
Research Centre FRA-002
Saint-Denis
Italy3 sites
Research Centre ITA-001
Naples
Research Centre ITA-002
Ragusa
Research Centre ITA-003
Syracuse
About this study
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
- Being tested
- BiOSS LIM C
- Keywords
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Left Main Bifurcation
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiOSS LIM CDevice
Also called ALEX Plus, XIENCE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BiOSS LIM C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
Patient-oriented Composite Endpoint (PoCE)
PoCE is defined as a composite of all-cause death, stroke, any MI, and any revascularization
Measured: 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
Measured: 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
Measured: 12 months
Mortality
Occurrence of death of any cause
Measured: 12 months
Stroke
Occurrence of stroke (with a modified Rankin Scale >=1)
Measured: 12 months
Myocardial Infarction
Occurrence of myocardial infarction
Measured: 12 months
Revascularization
Occurrence of any revascularization (percutaneous coronary intervention or coronary artery bypass grafting)
Measured: 12 months
Stent Thrombosis
Occurrence of any stent thrombosis according to standard definitions provided by the Academic Research Consortium
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start10 Aug 2018
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Why it stopped: COVID-19; safety concerns; funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECRI bv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV, Balton Sp.zo.o.
- Responsible party
- Sponsor
- Investigators
- Robert Gil, Prof., Principal investigator, Central Clinical Hospital of the Ministry of Interior in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508219
- Sponsor's protocol ID
- ECRI-010
- Acronym
- POLBOS-LM
- Status last verified
- Aug 2025
- First submitted
- 16 Apr 2018
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT03508219
- Acronym / sponsor ID
- POLBOS-LM / ECRI-010
- Conditions
- Coronary Stenosis
- Keywords
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Left Main Bifurcation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19; safety concerns; funding
- Enrolment
- 130 participants (actual)
- Lead sponsor
- ECRI bvIndustry (pharma, biotech, devices)
- Collaborators
- Cardialysis BV, Balton Sp.zo.o.
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BiOSS LIM C | Experimental | Device: BiOSS LIM CThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiOSS LIM CAlso: ALEX Plus, XIENCEThe 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. | Device | BiOSS LIM C |
Primary outcome
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.
8 secondary outcomes
Patient-oriented Composite Endpoint (PoCE)
Time frame: 12 months
Target Vessel Failure
Time frame: 12 months
Target Lesion Failure
Time frame: 12 months
Mortality
Time frame: 12 months
Stroke
Time frame: 12 months
Myocardial Infarction
Time frame: 12 months
Revascularization
Time frame: 12 months
Stent Thrombosis
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Rationale and design of the POLBOS LM studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Gil, Prof. principal investigator
Central Clinical Hospital of the Ministry of Interior in Warsaw
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiOSS LIM C in people with Coronary Stenosis, run by ECRI bv at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Poland, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.