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)
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
- 否
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
prof. C. von Birgelen
Professor C. von Birgelen
Thorax Centrum Twente
