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临床试验/NCT06475625
NCT06475625进行中(未招募)4 期

Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease Undergoing Percutaneous Coronay Intervention : A Multicenter, Prospective All-comers Registry

The Catholic University of Korea2 个研究点 分布在 2 个国家目标入组 3,113 人开始时间: 2019年10月22日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
3,113
试验地点
2
主要终点
Target-lesion failure (TLF)

研究概览

简要总结

Orsiro™ or Orsiro_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. In several prior studies, ultrathin strut sirolimus-eluting stent (Orsiro®) showed better outcomes in terms of target lesion failure or target lesion revascularization compared to other contemporary stents. Chronic kidney disease (CKD) is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis following percutaneous coronary interventin (PCI), because the patients with CKD have more complex coronary lesion characteristics, severe calcification, and diffuse plaque of the coronary artery. However, there is a paucity of data regarding clinical efficacy of Orsiro® in CKD population. Therefore, this study aims to investigate the differences in clinical outcomes according to renal function in patients undergoing PCI with Orsiro™ or Orsiro_Mission™ stents. After patients will be divided into three groups according to the renal function; normal or mild renal dysfunction (eGFR ≥ 60 ml·min - 1·1.73㎡), moderate renal dysfunction ( 30≤ eGFR< 60 ml·min - 1·1.73㎡), and severe renal dysfunction (eGFR < 30 ml·min -1·1.73㎡), the clinical outcome will be investigated among groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years of age or older
  • Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents

排除标准

  • Patient with a life expectancy of less than one year
  • Patient who used another drug-eluting stent for percutaneous coronary intervention at study registration time
  • Cardiogenic shock
  • Pregnancy

结局指标

主要结局

Target-lesion failure (TLF)

时间窗: Within one year after the intervention

Number of participants with Target-lesion failure (TLF), defined as composite of cardiac death, target vessel-related myocardial infarction (TVMI) and ischemia-driven target-lesion revascularization (TLR) at 1 year

次要结局

  • Number of participants with myocardial infarction(Within three years after the intervention)
  • Number of participants with composite of death or myocardial infarction(Within three years after the intervention)
  • Number of participants with composite of cardiac death or myocardial infarction(Within three years after the intervention)
  • Number of participants with cardiac death(Within three years after the intervention)
  • Number of participants with target-vessel revascularization(Within three years after the intervention)
  • Number of participants with target-vessel failure(Within three years after the intervention)
  • Number of participants with all cause death(Within three years after the intervention)
  • Number of participants with target-lesion revascularization(Within three years after the intervention)
  • Number of participants with stent thrombosis(Within three years after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahn-Won Park

Professor

The Catholic University of Korea

研究点 (2)

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