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

Coronary Stenosis Clinical Trial

— POLBOS LM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03508219
• Other study ID #: ECRI-010
• Status: Terminated
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2022
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

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.

Locations

Country	Name	City	State
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
Italy	Research Centre ITA-001	Naples
Italy	Research Centre ITA-002	Ragusa
Italy	Research Centre ITA-003	Syracuse
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

Sponsors (3)

Lead Sponsor	Collaborator
ECRI bv	Balton Sp.zo.o., Cardialysis BV

Countries where clinical trial is conducted

France,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	POCE defined as composite of all-cause death, stroke, any MI, and any revascularization		30 days; 6 months
Secondary	Target Vessel Failure defined as cardiac death, Target vessel MI, and clinically indicated target vessel revascularization		30 days; 6 months; 12 months
Secondary	Target Lesion Failure (device oriented composite endpoint) defined as cardiac death, target vessel MI, and clinically indicated target lesion revascularization		30 days; 6 months ; 12 months
Secondary	Mortality		30 days; 6 months; 12 months
Secondary	Stroke		30 days; 6 months; 12 months
Secondary	Myocardial infarction		30 days; 6 months; 12 months
Secondary	Revascularization		30 days; 6 months; 12 months
Secondary	Stent thrombosis according to Academic Research Consortium classification		30 days; 6 months; 12 months