POLish Bifurcation Optimal Treatment Strategy (POLBOS 3) Randomized Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 518
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
BiOSS LIM C
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).
干预措施: Percutaneous Coronary Intervention with stent implantation (Procedure)
regular 2nd generation DES
Intervention: Percutaneous coronary intervention (PCI) with regular drug-eluting stent implantation (rDES).
rDES well-tested and available on the market. Xience, Orsiro, Resulte Integrity
干预措施: Percutaneous Coronary Intervention with stent implantation (Procedure)
结局指标
主要结局
MACE
时间窗: 12 months
Major Cardiovascular Events rate (cardiac death, myocardial infarction, target lesion revascularization);
次要结局
- All cause death(12 months)
- cardiac death(12 months)
- myocardial infarction(12 months)
- target lesion revascularization(12 months)
研究者
Jacek Bil
Principal Investigator
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland