BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations

Study Overview
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Brief Summary
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Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.

Detailed Description
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Single stent implantation in the main vessel-main branch across a side branch is the default strategy (provisional T-stenting, PTS) in all patients enrolled. Bifurcation lesions are assessed according to Medina classification using an index of 1 for stenosis greater than 50% and 0 for no stenosis (visual estimation). There is no restriction regarding lesion length in patient selection. If required, additional stent can be implanted (Alex Plus in the BiOSS Lim C Group). A stent in a side branch (Alex Plus in the BiOSS Lim C Group) should be implanted only if there is proximal residual stenosis greater than 70% after balloon dilatation and/or significant flow impairment after main vessel - main branch stenting and/or a flow limiting dissection. The implantation protocol for bifurcation is as follows: wiring of both branches; main vessel predilatation and/or side branch predilatation according to the operator's decision; stent implantation (inflation for at least 20 s); proximal optimization technique (POT) side branch postdilatation/side branch stent implantation if necessary final kissing balloon inflation at operator's discretion. Second proximal optimization technique (re-POT)

Official Title
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POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention with stent implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiOSS LIM C<br>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). | Procedure: Percutaneous Coronary Intervention with stent implantation<br>* PCI with BiOSS LIM C or rDES depending on the randomization<br>|
| Active Comparator: regular 2nd generation DES<br>Intervention: Percutaneous coronary intervention (PCI) with regular drug-eluting stent implantation (rDES). rDES well-tested and available on the market. Xience, Orsiro, Resulte Integrity | Procedure: Percutaneous Coronary Intervention with stent implantation<br>* PCI with BiOSS LIM C or rDES depending on the randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization); | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | All cause death | 12 months | 
| cardiac death | cardiac death | 12 months | 
| myocardial infarction | myocardial infarction | 12 months | 
| target lesion revascularization | target lesion revascularization | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dedicated bifurcation stent, non-LM bifurcation, sirolimus-eluting stent