临床试验/NCT01426139

NCT01426139已完成不适用

BIOTRONIK-Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in the Treatment of Patients With Single de Novo Coronary Artery Lesions in an Indian Population

Biotronik AG8 个研究点分布在 1 个国家目标入组 120 人开始时间: 2011年8月最近更新: 2013年4月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Biotronik AG
入组人数: 120
试验地点: 8
主要终点: In-Stent Late Lumen Loss

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subject has provided a written informed consent
•Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries
•The target lesion length is ≤ 26 mm
•The target reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm

排除标准

•Evidence of myocardial infarction within 72 hours prior to index procedure
•Unprotected left main coronary artery disease (stenosis >50%)
•Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
•Target lesion involves a side branch > 2.0 mm in diameter
•Heavily calcified lesion
•Target lesion is located in or supplied by an arterial or venous bypass graft

结局指标

主要结局

In-Stent Late Lumen Loss

时间窗: 9 months post index procedure

次要结局

未报告次要终点

研究者

发起方

Biotronik AG

申办方类型

Industry

责任方

Sponsor

研究点 (8)

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