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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
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.
Research Centre FRA-001
Aix-en-Provence, France
Research Centre FRA-004
Bron, France
Research Centre FRA-003
Grenoble, France
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. The safety and efficacy of the BiOSS LIM C® stent with respect to a PoCE at 12 months in a real world LM bifurcation population compared with a pre-specified performance goal was not confirmed. The POLBOS LM study showed that the BiOSS LIM C® stent was not non-inferior to the XIENCE stent for percutaneous treatment of the LM disease.
Time frame: 12 months
Patient-oriented Composite Endpoint (PoCE)
PoCE is defined as a composite of all-cause death, stroke, any MI, and any revascularization
Time frame: 12 months
Target Vessel Failure
Target Vessel Failure is defined as the composite of cardiac death, target vessel MI, and clinically indicated target vessel revascularization
Time frame: 12 months
Target Lesion Failure
Target Lesion Failure is defined as a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization
Time frame: 12 months
Mortality
Occurrence of death of any cause
Time frame: 12 months
Stroke
Occurrence of stroke (with a modified Rankin Scale \>=1)
Time frame: 12 months
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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
...and 5 more locations
Myocardial Infarction
Occurrence of myocardial infarction
Time frame: 12 months
Revascularization
Occurrence of any revascularization (percutaneous coronary intervention or coronary artery bypass grafting)
Time frame: 12 months
Stent Thrombosis
Occurrence of any stent thrombosis according to standard definitions provided by the Academic Research Consortium
Time frame: 12 months