CTRI/2022/02/040336尚未招募4 期
A Single centric, open label , observational , retrospective post market follow up Study to evaluate Safety and Performance of Sirolimus Eluting Coronary Stent System
Multimedics LLP0 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
- Pms
入排标准
入选标准
- •Subjects with ischemic heart disease due to coronary artery lesion
- •Subjects implanted with Sirolimus Eluting Coronary Stent from the manufacturer via Percutaneous Transluminal Coronary Angioplasty (PTCA)
排除标准
- •-Subjects expect in those with known allergies
- •-Subjects who are indicated for coronary bypass surgery.
- •-Subjects who exhibit angiographic evidence of existing thrombus.
- •-Subjects allergic to L605 Chromium cobalt.
- •-Subjects with a contradiction for anti-platelet / anti-coagulant therapy, this includes patients who have had major surgery, an obstetrical delivery organ biopsy, or puncture of a non- compressible vessel within 14 day of this procedure.
- •-Subjects with a history of gastrointestinal bleeding, recent C.V.A., diabetic hemorrhagic retinopathy, or any condition compromised by prolonged anti-coagulant.
- •-Subjects who have experienced a recent (less than 1 week) acute myocardial infarction.
- •-Subjects with diffuse disease, defined as long segments of abnormal vessel without interposed normal vessel.
- •-Subjects who have transplants.
- •-Subjects who got implanted with any other manufacturer Sirolimus Eluting Coronary Stent System
研究者
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