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临床试验/NCT02412501
NCT02412501已完成不适用

A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study

Medtronic Vascular34 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2015年4月6日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
34
主要终点
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
研究概览研究设计入排标准研究组 & 干预措施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 purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries that allows the use of a 2.0 mm diameter stent.

研究设计

研究类型
Interventional
分配方式
Na
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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery
  • •Must have evidence of ischemic heart disease
  • •Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
  • •Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

排除标准

  • •Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • •History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  • •History of a stroke or transient ischemic attack (TIA) within the prior 6 months
  • •Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  • •History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • •Concurrent medical condition with a life expectancy of less than 12 months
  • •Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
  • •Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation

研究组 & 干预措施

Device

Other

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent

干预措施: Resolute Onyx Stent - 2.0 mm (Device)

结局指标

主要结局

Number of Participants With Target Lesion Failure at 12 Months Post-Procedure

时间窗: 12 Months

Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.

次要结局

  • Number of Participants With Cardiac Death at 12 Months Post Procedure(12 Months)
  • Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure(12 Months)
  • Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure(12Months)
  • Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure(24 Months)
  • Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure(12 Months)
  • Number of Participants With Cardiac Death at 24 Months Post Procedure(24 Months)
  • Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure(12 Months)
  • Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure(24 Months)
  • Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure(24 Months)
  • Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure(24 Months)
  • Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure(24 Months)
  • Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure(36 Months)
  • Number of Participants With Cardiac Death at 36 Months Post Procedure(36 Months)
  • Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure(36 Months)
  • Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure(36 Months)
  • Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure(36 Months)
  • Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure(36 Months)

研究者

发起方
Medtronic Vascular
申办方类型
Industry
责任方
Sponsor

研究点 (34)

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