CTRI/2017/03/008167尚未招募4 期
A prospective, single-centre, observational, real world, post-marketing surveillance to evaluate safety and performance of the BioMimeâ?¢ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions
Meril Life Sciences Pvt Ltd0 个研究点目标入组 257 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
- 入组人数
- 257
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
- •1.The patient must be at least 18 years of age. 2.Significant native coronary artery stenosis (more than 50% by visual estimate) with lesion length of less and equal to 56 mm.
- •3.The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
排除标准
- •1. Patients who are actively participating in another drug or device investigational study.
- •2.Patients who are unwilling to participate in the study.
- •3.Patients contraindicated to any of the following medications aspirin, heparin, clopidogrel, cobalt chromium contrast agents and sirolimus.
- •4.Female patient with known pregnancy or who are lactating.
研究者
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