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

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ClinicalTrials.gov Identifier: NCT03508219
Recruitment Status : Suspended (COVID-19)
First Posted : April 25, 2018
Last Update Posted : December 19, 2020
Sponsor:
Collaborators:
Cardialysis BV
Balton Sp.zo.o.
Information provided by (Responsible Party):
ECRI bv

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Stenosis Device: BiOSS LIM C Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. POCE defined as composite of all-cause death, stroke, any MI, and any revascularization [ Time Frame: 30 days; 6 months ]
  2. Target Vessel Failure defined as cardiac death, Target vessel MI, and clinically indicated target vessel revascularization [ Time Frame: 30 days; 6 months; 12 months ]
  3. Target Lesion Failure (device oriented composite endpoint) defined as cardiac death, target vessel MI, and clinically indicated target lesion revascularization [ Time Frame: 30 days; 6 months ; 12 months ]
  4. Mortality [ Time Frame: 30 days; 6 months; 12 months ]
  5. Stroke [ Time Frame: 30 days; 6 months; 12 months ]
  6. Myocardial infarction [ Time Frame: 30 days; 6 months; 12 months ]
  7. Revascularization [ Time Frame: 30 days; 6 months; 12 months ]
  8. Stent thrombosis according to Academic Research Consortium classification [ Time Frame: 30 days; 6 months; 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508219


Locations
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France
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
Italy
Research Centre ITA-001
Naples, Italy
Research Centre ITA-002
Ragusa, Italy
Research Centre ITA-003
Syracuse, Italy
Poland
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
Sponsors and Collaborators
ECRI bv
Cardialysis BV
Balton Sp.zo.o.
Investigators
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Study Chair: Patrick W Serruys, Prof. Imperial College London
Principal Investigator: Robert Gil, Prof. Central Clinical Hospital of the Ministry of Interior in Warsaw
More Information
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Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT03508219    
Other Study ID Numbers: ECRI-010
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ECRI bv:
Coronary Artery Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Left Main Bifurcation
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases