跳至主要内容
临床试验/NCT00866398
NCT00866398已完成不适用

Economic Evaluation German Drug-Eluting Stent Registry

Charite University, Berlin, Germany0 个研究点目标入组 3,973 人开始时间: 2005年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,973
主要终点
Cost equivalence of drug-eluting coronary stents versus bare metal stents

研究概览

简要总结

Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.

The study "Economic Evaluation of the German Drug-Eluting Stent Registry" examines the cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, and re-intervention rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Indication for coronary stent implantation
  • Additional inclusion criteria BMS cohort:
  • Acute Coronary Syndrome
  • Diabetes Mellitus
  • Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
  • 3-Vessel Disease

排除标准

  • 未提供

结局指标

主要结局

Cost equivalence of drug-eluting coronary stents versus bare metal stents

时间窗: 12 months

次要结局

  • MACCE(12 months)
  • Quality of life(12 months)

研究者

申办方类型
Other

相似试验