Novel Sirolimus-eluting Stent Prolim® With a Biodegradable Polymer in the All-comers Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 主要终点
- The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).
研究概览
简要总结
The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.
详细描述
Investigators prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome, treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15% of patients (randomly chosen) underwent optical coherence tomography analysis. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization after 12 months.
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
- •age ≥ 18 years old,
- •stable coronary artery disease (SCAD) or acute coronary syndrome (unstable angina - UA, non-ST elevation myocardial infarction - NSTEMI or ST-elevation myocardial infarction - STEMI) and
- •signed informed consent
排除标准
- •inability to take dual antiplatelet therapy for 12 months,
- •left ventricular ejection fraction ≤ 30%,
- •chronic total occlusions, and
- •in-stent restenosis
结局指标
主要结局
The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).
时间窗: 12 months
consisting of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR)
次要结局
- The percentage of covered struts assessed in optical coherence tomography (OCT)(12 months)
- The neointima volume assessed in OCT(12 months)
- Late lumen loss (LLL)(12 moths)
- Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.(12 moths)
- The device success rate(intraoperative)
研究者
Jacek Bil
MD, PhD
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland