POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI) (POLBOS LM)
Primary Purpose
Coronary Stenosis
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BiOSS LIM C
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Stenosis focused on measuring Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Left Main Bifurcation
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.
Sites / Locations
- Research Centre FRA-001
- Research Centre FRA-004
- Research Centre FRA-003
- Research Centre FRA-002
- Research Centre ITA-001
- Research Centre ITA-002
- Research Centre ITA-003
- Research Centre PL-006
- Research Centre PL-007
- Research Centre PL-004
- Research Centre PL-005
- Research Centre PL-001
- Research Centre PL-008
- Research Centre PL-002
- Research Centre PL-003
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BiOSS LIM C
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
POCE defined as composite of all-cause death, stroke, any MI, and any revascularization
Target Vessel Failure defined as cardiac death, Target vessel MI, and clinically indicated target vessel revascularization
Target Lesion Failure (device oriented composite endpoint) defined as cardiac death, target vessel MI, and clinically indicated target lesion revascularization
Mortality
Stroke
Myocardial infarction
Revascularization
Stent thrombosis according to Academic Research Consortium classification
Full Information
NCT ID
NCT03508219
First Posted
April 16, 2018
Last Updated
July 25, 2022
Sponsor
ECRI bv
Collaborators
Cardialysis BV, Balton Sp.zo.o.
1. Study Identification
Unique Protocol Identification Number
NCT03508219
Brief Title
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
Acronym
POLBOS LM
Official Title
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECRI bv
Collaborators
Cardialysis BV, Balton Sp.zo.o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
Keywords
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Left Main Bifurcation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BiOSS LIM C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BiOSS LIM C
Other Intervention Name(s)
ALEX Plus, XIENCE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Non-inferiority comparison of Patient-oriented composite endpoint (PoCE) of BiOSS LIM C to a pre-specified objective performance goal (OPC).
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
POCE defined as composite of all-cause death, stroke, any MI, and any revascularization
Time Frame
30 days; 6 months
Title
Target Vessel Failure defined as cardiac death, Target vessel MI, and clinically indicated target vessel revascularization
Time Frame
30 days; 6 months; 12 months
Title
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
Title
Mortality
Time Frame
30 days; 6 months; 12 months
Title
Stroke
Time Frame
30 days; 6 months; 12 months
Title
Myocardial infarction
Time Frame
30 days; 6 months; 12 months
Title
Revascularization
Time Frame
30 days; 6 months; 12 months
Title
Stent thrombosis according to Academic Research Consortium classification
Time Frame
30 days; 6 months; 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Gil, Prof.
Organizational Affiliation
Central Clinical Hospital of the Ministry of Interior in Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Centre FRA-001
City
Aix en Provence
Country
France
Facility Name
Research Centre FRA-004
City
Bron
Country
France
Facility Name
Research Centre FRA-003
City
Grenoble
Country
France
Facility Name
Research Centre FRA-002
City
Saint-Denis
Country
France
Facility Name
Research Centre ITA-001
City
Naples
Country
Italy
Facility Name
Research Centre ITA-002
City
Ragusa
Country
Italy
Facility Name
Research Centre ITA-003
City
Syracuse
Country
Italy
Facility Name
Research Centre PL-006
City
Katowice
Country
Poland
Facility Name
Research Centre PL-007
City
Krakow
Country
Poland
Facility Name
Research Centre PL-004
City
Olsztyn
Country
Poland
Facility Name
Research Centre PL-005
City
Poznan
Country
Poland
Facility Name
Research Centre PL-001
City
Warsaw
Country
Poland
Facility Name
Research Centre PL-008
City
Warsaw
Country
Poland
Facility Name
Research Centre PL-002
City
Zabrze
Country
Poland
Facility Name
Research Centre PL-003
City
Zabrze
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
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