POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Corona… (NCT03508219) | Clinical Trial Compass
TerminatedNot Applicable
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
Stopped: COVID-19; safety concerns; funding
France, Italy130 participantsStarted 2018-08-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 t…
What they're measuring
1
Non-inferiority Comparison of Patient-oriented Composite Endpoint (PoCE) of BiOSS LIM C to a Pre-specified Objective Performance Goal (OPC).