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临床试验/NCT01674803
NCT01674803已完成不适用

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

Foundation of Cardiovascular Research and Education Enschede1 个研究点 分布在 1 个国家目标入组 3,514 人开始时间: 2012年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,514
试验地点
1
主要终点
Target vessel failure (TVF)

研究概览

简要总结

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Minimum age of 18 years.
  • Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement.
  • Capable of providing informed consent.
  • Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.

排除标准

  • Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy.
  • Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
  • Participation in another randomized drug or device trial before reaching primary endpoint.
  • Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year.
  • Known pregnancy

结局指标

主要结局

Target vessel failure (TVF)

时间窗: 1 year

Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.

次要结局

  • Target lesion failure (TLF)(1 year)

研究者

发起方
Foundation of Cardiovascular Research and Education Enschede
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. C. von Birgelen

Professor C. von Birgelen

Thorax Centrum Twente

研究点 (1)

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