NCT03471845进行中（未招募）不适用
A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
Medtronic Vascular1 个研究点 分布在 1 个国家目标入组 591 人开始时间: 2018年3月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 591
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.
详细描述
This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).
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
- •The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the IB of Resolute Onyx stent.
- •The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels [2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm
排除标准
- •Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- •PCI of the target vessel within 9 months prior to the procedure
- •Active bleeding
- •Subjects with a life expectancy of less than 12 months
- •Participation in another clinical study
- •Pregnant, or lactating women
研究组 & 干预措施
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Experimental
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
干预措施: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Device)
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
TLF
次要结局
- Device Success(at the end of the index procedure or during hospital stay:estimated 7 days)
- Lesion Success(at the end of the index procedure or during hospital stay: estimated 7 days)
- Procedure Success(at the end of the index procedure or during hospital stay: estimated 7 days)
- Major Adverse Cardiac Events (MACE)(30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years)
- Death (Cardiac and Non-cardiac)(30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years)
- Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))(30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years)
- All revascularizations(30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years)
- Target Vessel Failure (TVF)(30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years)
- Target Lesion Failure (TLF)(30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years)
- Stent Thrombosis (ST)(30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years)
- In-stent late luminal loss(9 months)
- In-segment late luminal loss(9 months)
- In-stent and in-segment percent diameter stenosis (%DS)(9 months)
- In-stent and in-segment binary restenosis rate(9 months)
- In-stent and in-segment minimal luminal diameter (MLD)(9 months)
研究者
研究点 (1)
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