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临床试验/NCT04482972
NCT04482972招募中不适用

Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience

Norfolk and Norwich University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2017年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

Drug coated balloon (DCB) is a relatively new technology which allows the treatment of coronary artery disease without permanent implantation of a metallic scaffold (stent) in the coronary artery. It is recommended by international guidelines for the treatment of in-stent restenosis (i.e. when a previously implanted stent in the coronary artery develops narrowings again). Data on patient outcomes of patients treated with DCB for de novo coronary artery disease (narrowings in artery supplying blood to the heart that has not been previously treated with a stent) are limited to relatively small studies. In our institution, DCBs have been used over the last 10 years and we have developed a large clinical database. We intend to compare the outcomes of all our patients treated clinically with DCB vs patients treated with drug eluting stent (DES). We will, incorporate all patients presenting either with myocardial infarction (heart attack) or stable angina. Our main outcomes will be: Primary 1) mortality Secondary 1) cardiac mortality 2) cardiac rehospitalisation3) composite of cardiac mortality and cardiac rehospitalisation

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

All-cause mortality

时间窗: Through study completion, an average of 10 years

All cause death will be defined as death due to any cause

次要结局

  • Cardiac mortality - either MI, TVR, Acute Vessel Closure or TLR(Through study completion, an average of 10 years)
  • Composite of cardiac death and cardiac rehospitalisation(Through study completion, an average of 10 years)
  • Cardiac rehospitalisation(Through study completion, an average of 10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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