Evaluation of Effectiveness and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease; A Multicenter, Prospective, Observational Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 20
- 主要终点
- Target lesion failure
研究概览
简要总结
This study is to evaluation the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.
详细描述
Study objectives:
From this observational prospective study, the efficacy and safety of Zotarolimus-Eluting Stent in patients with coronary artery disease longer than 25mm is planned to be investigated.
Background:
Long coronary artery lesions are observed in 20% of all coronary interventions, and are associated with poor clinical outcomes. Zotarolimus-Eluting Stents are a new type of stent that combines the advantages of an Endeavour Resolute stent (drug eluting stent) and Integrity stent (bare metal stent). In other words, BioLinx polymer is used which is an advantage of Endeavour Resolute stent to secure clinical efficiency through stable drug release while ensuring flexibility and excellent deliverability, which is the advantage of Integrity stent. To date, there are only few studies to evaluate the efficacy and safety of Zotarolimus-Eluting Stent in the treatment of coronary artery disease. Therefore, the investigators planned to carry out a multicenter, prospective observational study to evaluated the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years old
- •Evidence of myocardial ischemia and coronary artery diameter stenosis≥ 50% and lesion length ≥ 25mm
- •At least 2.5 mm diameter coronary vessel by visual estimation
- •Patients treated with Zotarolimus-eluting stent
排除标准
- •Previous coronary stent implantation
- •Patients perticipated in other clinical trials of drugs or device
- •Target vessel saphenous vein graft
- •In-stent re-stenosis lesion
- •Contraindicated to anti-platelet agents or hypersensitivity
- •Past history of malignancy within 5 years
- •History of anaphylaxis to contrast agent
- •Pregnancy and lactation
- •Life expectancy < 1-year
- •End stage renal disease on dialysis
结局指标
主要结局
Target lesion failure
时间窗: Index admission to 12 months
Composite endpoint of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to target vessel
次要结局
- Target vessel revascularization(Index admission, 1 month, 6 months, 12 months)
- All-cause death(Index admission, 1 month, 6 months, 12 months)
- All-cause death or Myocardial infarction(Index admission, 1 month, 6 months, 12 months)
- Stent thrombosis(Index admission, 1 month, 6 months, 12 months)
- Cardiac death(Index admission, 1 month, 6 months, 12 months)
- Myocardial Infarction(Index admission, 1 month, 6 months, 12 months)
- Target lesion revascularization(Index admission, 1 month, 6 months, 12 months)
- Cardiac death or Myocardial infarction(Index admission, 1 month, 6 months, 12 months)
研究者
Min Chul Kim
Associate Professor
Chonnam National University Hospital