POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 28
- 主要终点
- Non-inferiority Comparison of Patient-oriented Composite Endpoint (PoCE) of BiOSS LIM C to a Pre-specified Objective Performance Goal (OPC).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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
- •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 time prior to enrollment
- •Patient requiring or may require additional surgery (cardiac or non-cardiac) within one year
- •Ongoing myocardial infarction or recent myocardial infarction with cardiac biomarker levels still elevated.
- •Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30mL/min, or patient on dialysis).
- •Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor.
- •Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 12 months.
- •Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential).
- •Concurrent medical condition with a life expectancy of less than 12 months.
- •The patient is unwilling/not able to return for outpatient clinic at 12 month follow-up.
- •Currently participating in another trial and not yet at its primary endpoint.
研究组 & 干预措施
BiOSS LIM C
The treatment strategy consists of contemporary PCI of the left-main bifurcation, using the BiOSS LIM C stent system, following diagnostic angiography demonstrating significant distal unprotected left main disease and local Heart Team discussion applying the anatomic SYNTAX Score.
干预措施: BiOSS LIM C (Device)
结局指标
主要结局
Non-inferiority Comparison of Patient-oriented Composite Endpoint (PoCE) of BiOSS LIM C to a Pre-specified Objective Performance Goal (OPC).
时间窗: 12 months
POCE defined as a composite measure of: All-cause mortality, Stroke (Modified Ranking Scale (mRS) ≥1), Any Myocardial infarction (MI) (includes non target vessel territory), Any unplanned revascularization for ischemia (includes all target and nontarget vessels). OPC based on data collected in Excel-study. The safety and efficacy of the BiOSS LIM C® stent with respect to a PoCE at 12 months in a real world LM bifurcation population compared with a pre-specified performance goal was not confirmed. The POLBOS LM study showed that the BiOSS LIM C® stent was not non-inferior to the XIENCE stent for percutaneous treatment of the LM disease.
次要结局
- Mortality(12 months)
- Patient-oriented Composite Endpoint (PoCE)(12 months)
- Target Vessel Failure(12 months)
- Target Lesion Failure(12 months)
- Stroke(12 months)
- Revascularization(12 months)
- Stent Thrombosis(12 months)
- Myocardial Infarction(12 months)