Regular DES Versus BiOSS Expert® Stent in Coronary Bifurcation Treatment - Randomized, Multicenter, Open-label, Controlled POLBOS I (POLish Bifurcation Optimal Stenting) Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (PCI) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials with DBS.
The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® (Balton, PL).
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
结局指标
主要结局
MACE
时间窗: 12 months
Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) with or without ST-segment elevation and need for repeated revascularization of the target lesion (TLR).
次要结局
- late lumen loss(12 months)
- myocardial infarction(12 months)
- cardiac death(12 months)
- all-cause death(12 months)
- Target lesion revascularization(12 months)
- Target vessel revascularization(12 months)
研究者
Jacek Bil
MD, PhD
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland