NCT02038127招募中不适用
Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 3
- 主要终点
- Device-oriented composite outcome
研究概览
简要总结
Comparison of
- Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore
- Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott, USA
- Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent Medtronic, USA in patients with coronary artery disease treated with percutaneous coronary intervention
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
- •Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- •Subject must have significant stenosis (>50% by visual estimate) on a native or in-stent coronary artery
- •Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis >75%, evidence of myocardial ischemia does not have to be documented
排除标准
- •Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)
- •Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months.
- •Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study
- •Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment
- •Subject with non-cardiac co-morbid condition with life expectancy < 2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- •Subject with cardiogenic shock at presentation
- •Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period
结局指标
主要结局
Device-oriented composite outcome
时间窗: 24 months
Device-oriented composite consisted of cardiac death, MI not clearly attributable to a nontarget vessel, and clinically indicated TLR at 24-month clinical follow-up
次要结局
- ARC defined stent thrombosis(24 months)
- ARC defined stent thrombosis(12 months)
- Target vessel revascularization(12 months)
- Target vessel revascularization(24 months)
- Patient-oriented composite outcome(24 months)
研究者
Young Jin Youn, MD, PhD
Assistant Professor
Yonsei University
研究点 (3)
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