Clinical trial NCT03508219: POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
Official title: POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Stenosis
Keywords: Coronary Artery Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Left Main Bifurcation
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Cardialysis BV
name: Balton Sp.zo.o.
First posted: 2018-04-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Non-inferiority comparison of Patient-oriented composite endpoint (PoCE) of BiOSS LIM C to a pre-specified objective performance goal (OPC).
timeFrame: 12 months
Secondary outcomes:
measure: POCE defined as composite of all-cause death, stroke, any MI, and any revascularization
timeFrame: 30 days; 6 months
measure: Target Vessel Failure defined as cardiac death, Target vessel MI, and clinically indicated target vessel revascularization
timeFrame: 30 days; 6 months; 12 months
measure: Target Lesion Failure (device oriented composite endpoint) defined as cardiac death, target vessel MI, and clinically indicated target lesion revascularization
timeFrame: 30 days; 6 months ; 12 months
measure: Mortality
timeFrame: 30 days; 6 months; 12 months
measure: Stroke
timeFrame: 30 days; 6 months; 12 months
measure: Myocardial infarction
timeFrame: 30 days; 6 months; 12 months
measure: Revascularization
timeFrame: 30 days; 6 months; 12 months
measure: Stent thrombosis according to Academic Research Consortium classification
timeFrame: 30 days; 6 months; 12 months
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Research Centre FRA-001
city: Bron
country: France
facility: Research Centre FRA-004
city: Grenoble
country: France
facility: Research Centre FRA-003
city: Saint-Denis
country: France
facility: Research Centre FRA-002
city: Naples
country: Italy
facility: Research Centre ITA-001
city: Ragusa
country: Italy
facility: Research Centre ITA-002
city: Syracuse
country: Italy
facility: Research Centre ITA-003
city: Katowice
country: Poland
facility: Research Centre PL-006
city: Krakow
country: Poland
facility: Research Centre PL-007
city: Olsztyn
country: Poland
facility: Research Centre PL-004
city: Poznan
country: Poland
facility: Research Centre PL-005
city: Warsaw
country: Poland
facility: Research Centre PL-001
city: Warsaw
country: Poland
facility: Research Centre PL-008
city: Zabrze
country: Poland
facility: Research Centre PL-002
city: Zabrze
country: Poland
facility: Research Centre PL-003
Study officials:
affiliation: Central Clinical Hospital of the Ministry of Interior in Warsaw
name: Robert Gil, Prof.
role: PRINCIPAL_INVESTIGATOR
References: