NCT03344653已完成不适用
Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Medtronic Vascular172 个研究点 分布在 13 个国家目标入组 2,000 人开始时间: 2017年11月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 172
- 主要终点
- Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis
研究概览
简要总结
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
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
- Single (Participant)
盲法说明
Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).
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
- •Age ≥ 75 years old
- •Any prior documented intracerebral bleed
- •Any documented stroke in the last 12 months
- •Hospital admission for bleeding during the prior 12 months
- •Non-skin cancer diagnosed or treated ≤3 years
- •Planned surgery within the next 12 months
- •Renal failure defined as: Creatinine clearance <40 ml/min
- •Thrombocytopenia (PLT <100,000/mm3)
- •Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
排除标准
- •Pregnant and breastfeeding women
- •Subjects requiring a planned PCI procedure after 1 month of index procedure
- •Active bleeding at the time of inclusion
- •Cardiogenic shock
- •A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- •PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
- •Participation in another clinical study within 12 months after index procedure
- •Subjects with life expectancy of less than 2 years
结局指标
主要结局
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis
时间窗: 1 year post-procedure
Powered for non-inferiority against BioFreedom (control), is a composite of cardiac death, myocardial infarction and definite/probable stent thrombosis. The combined clinical outcome of cardiac death, MI or stent thrombosis
次要结局
- Major Cardiac Event(2 year post- procedure)
- Target Vessel Failure(2 year post-procedure)
- Cardiac Death(2 year post- procedure)
- Myocardial Infarction(2 year post-procedure)
- Stent Thrombosis(2 year post-procedure)
- Stroke(2 year post-procedure)
- Target Lesion Failure(2 year post-procedure)
- Bleeding(2 year post-procedure)
- Revascularization(2 year post-procedure)
- Procedure Success(2 year post-procedure)
- Device success(2 year post-procedure)
- Lesion Success(2 year post-procedure)
研究者
研究点 (172)
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