CTRI/2012/07/002808已完成4 期
A Prospective, Multi-Center Registry to assess Everolimus-Eluting Coronary Stent System (PROMUS Elementâ?¢) for Coronary Revascularization in an Indian Population of Unrestricted Patients - None
Institute of Cardio Vascular Diseases The Madras Medical Mission0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •CI1. Patients receiving PROMUS Element• stents.
- •3 Promus stents per patient
- •2 stents per artery
- •CI2.Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.
- •CI3.Patient is eligible for percutaneous coronary intervention (PCI)
- •CI4.Patient is willing to comply with all protocol-required follow-up evaluations.
排除标准
- •CE1.Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines, aspirin, contrast) that cannot be adequately pre-medicated.
- •CE2.Patient has any other serious medical illness (e.g., cancer, congestive heart failure - NYHA Class 3 and 4) that may reduce life expectancy to less than 12 months.
- •CE3.Patients with a mixture of other drug eluting stents
- •CE4.Pregnant and lactating females or females having positive pregnancy test (urine or serum)
- •CE5.Known/ Suspected case of Human Immunodeficiency Virus Infection
研究者
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