A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in Comparison With the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
- 试验地点
- 3
- 主要终点
- In-stent Late lumen loss measured by quantitative coronary angiography (QCA)
研究概览
简要总结
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.
详细描述
This study is a pre-Market, prospective, multi-center, open-label, randomized controlled trial. Subjects will be 1:1 randomized and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months (primary endpoint_LLL), and annual assessments from 1-5 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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, the IB of Resolute Onyx stent, and the IFU of Resolute Integrity 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 4.0 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
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
干预措施: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Device)
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
干预措施: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (Device)
结局指标
主要结局
In-stent Late lumen loss measured by quantitative coronary angiography (QCA)
时间窗: 9 months
Late lumen loss measured by quantitative coronary angiography (QCA)
次要结局
- Target Lesion Failure (TLF)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
- In-stent and in-segment percent diameter stenosis (%DS)(9 months)
- Device Success(at the end of the index procedure or during hospital stay: estimated 7 days)
- Stent Thrombosis (ST)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
- In-segment late luminal loss(9 months)
- 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, 1 year, 2 years,3 years, 4 years, 5 years)
- All revascularizations(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
- Lesion Success(at the end of the index procedure or during hospital stay: estimated 7 days)
- Death (Cardiac and Non-cardiac)(30 day, 6 months, 9 months, 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, 1 year, 2 years,3 years, 4 years, 5 years)
- Target Vessel Failure (TVF)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
- In-stent and in-segment binary restenosis rate(9 months)
- In-stent and in-segment minimal luminal diameter (MLD)(9 months)