NCT02809248撤回不适用
The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX-Stent Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- the ideal stent (coated stent or uncoated stent)
研究概览
简要总结
The aim of the study is to choose an optimal stent and to get further knowledge about the mechanisms of the engraftment of a stent.
The occurrence of a hyperplasia of neointima can be minimized by application of a coated stent and a concurrent safety four weekly dual thrombocytes therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •male and female patients with a severe dysfunction of liver
- •patient is planned a coronary stent implantation
- •adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
- •written informed consent prior to study participation
排除标准
- •younger than 18 years
- •pregnancy and breast-feeding
- •acute cardiac syndrome
- •contraindication against an intracardiac catheter
- •persons in dependence from the sponsor or working with the sponsor
- •participation in a parallel interventional clinical trial
- •patient has been committed to an institution by legal or regulatory order
研究组 & 干预措施
coated stent
Active Comparator
the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent)
干预措施: ZES (Device)
uncoated stent
Active Comparator
the patient get a uncoated coronary stent implantation (BMS - bare metal stent)
干预措施: BMS (Device)
结局指标
主要结局
the ideal stent (coated stent or uncoated stent)
时间窗: 5 weeks
次要结局
未报告次要终点
研究者
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