CTRI/2020/07/026564尚未招募4 期
EverPro-REGISTRY:To determine safety and performance of Everpro Everolimus-Eluting Coronary Stent System (EES) in all-comer patients with coronary artery disease (CAD) in one year follow-Up Period.
Sahajanand Laser Technology Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Males and Females more than 18 years of age.
- •2. Subjects who had signed the Hospital consent form.
- •3. The subjects who have been treated with PCI and implanted with Everpro Drug Eluting Stent as a part of their treatment of Coronary Artery Disease, without any further indication for Emergent Coronary Artery Bypass Graft Surgery
排除标准
- •1. Subjects who were not eligible for a PCI procedure. Or who were candidates for Urgent or planned elective Coronary Artery Bypass Surgery.
- •2. Subjects who are treated with stents other than Everpro stent.
- •3. Subjects who are known sensitive to Cobalt Chromium alloy, PLLA Polymer, Everolimus and its Analogues, Aspirin, Clopidogrel and analogues, and Contrast media.
- •4. Pregnant/lactating women during Index procedure. However, if pregnancy occurs during followâ??ups, the subject will not be excluded.
- •5. Subjects with more than Grade III Renal Insufficiency as indicated by Creatinine > 160 mcmol/L.
- •6. Subjects with short life expectancy less than the trial duration of 1 years (including patients with cancer, HIV/AIDS), documented LVEF <30%, history of Cardiac Failure, Structural heart disease, Myocardiopathies, Arrhythmia or other Comorbid conditions
研究者
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