BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations (POLBOS 3)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring dedicated bifurcation stent, non-LM bifurcation, sirolimus-eluting stent
Eligibility Criteria
Inclusion Criteria:
- Subject at least 18 years of age.
- Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
- Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
Exclusion Criteria:
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects who refuse to give informed consent.
- Subjects with LVEF<30%
- Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
- Distal LM stenosis
Sites / Locations
- Department of Invasive Cardiology Central Clinical Hospital of the Ministry of InteriorRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BiOSS LIM C
regular 2nd generation DES
Intervention: Percutaneous coronary intervention (PCI) with BiOSS LIM C stent implantation. The BiOSS LIM C® is a dedicated bifurcation balloon expandable stent made of cobalt-chromium alloy (strut thickness 70 µm) releasing sirolimus (1.4 µg/mm2) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids (PGLA). The degradation of the polymer lasts approximately 8 weeks. The BiOSS LIM C® stent consists of two main separate parts with different diameters: wider proximally, and distally smaller. The proximal part is always a bit shorter than the distal one (avg. 1 mm).
Intervention: Percutaneous coronary intervention (PCI) with regular drug-eluting stent implantation (rDES). rDES well-tested and available on the market. Xience, Orsiro, Resulte Integrity