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

NCT ID: NCT03508219

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2021-04-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BiOSS LIM C

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ALEX Plus; XIENCE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardialysis BV

INDUSTRY

Sponsor Role: collaborator

Balton Sp.zo.o.

INDUSTRY

Sponsor Role: collaborator

ECRI bv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Gil, Prof.

Role: PRINCIPAL_INVESTIGATOR

Central Clinical Hospital of the Ministry of Interior in Warsaw

Locations

Research Centre FRA-001

Aix-en-Provence, , France

Research Centre FRA-004

Bron, , France

Research Centre FRA-003

Grenoble, , France

Research Centre FRA-002

Saint-Denis, , France

Research Centre ITA-001

Naples, , Italy

Research Centre ITA-002

Ragusa, , Italy

Research Centre ITA-003

Syracuse, , Italy

Research Centre PL-006

Katowice, , Poland

Research Centre PL-007

Krakow, , Poland

Research Centre PL-004

Olsztyn, , Poland

Research Centre PL-005

Poznan, , Poland

Research Centre PL-001

Warsaw, , Poland

Research Centre PL-008

Warsaw, , Poland

Research Centre PL-002

Zabrze, , Poland

Research Centre PL-003

Zabrze, , Poland

Countries

France; Italy; Poland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://eurointervention.pcronline.com/article/treatment-with-a-dedicated-bifurcation-sirolimus-eluting-cobalt-chromium-stent-for-distal-left-main-coronary-artery-disease-rationale-and-design-of-the-polbos-lm-study

Rationale and design of the POLBOS LM study

Other Identifiers

ECRI-010

Identifier Type: -

Identifier Source: org_study_id