NCT02843633进行中（未招募）不适用
A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,203
- 试验地点
- 66
- 主要终点
- The incidence of clinically driven target lesion revascularization at twelve months
研究概览
简要总结
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
详细描述
In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
- •Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or more of the following:
- •Adjunctive oral anticoagulation treatment planned to continue after PCI
- •Age ≥ 75 years old
- •Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
- •Any prior intracerebral bleed
- •Any stroke in the last 12 months
- •Hospital admission for bleeding during the prior 12 months
- •Non skin cancer diagnosed or treated < 3 years, with a perceived increased risk for bleeding
- •Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI
- •Planned surgery that would require interruption of DAPT (within next 6 months)
- •Renal failure defined as: Creatinine clearance <40 ml/min
- •Thrombocytopenia (PLT <100,000/mm3)
- •Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
- •Expected non-compliance to prolonged DAPT for other medical reasons
排除标准
- •Pregnant and breastfeeding women
- •Patients expected not to comply with 1 month DAPT
- •Patients requiring a planned staged PCI procedure more than one week after the index procedure
- •Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
- •Active bleeding at the time of inclusion
- •Reference vessel diameter <2.25 - >4.0mm
- •Cardiogenic shock
- •Compliance with long-term single anti-platelet therapy unlikely
- •A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
- •PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
- •Participation in another clinical trial (12 months after index procedure)
- •Patients with a life expectancy of < 12 months
- •Patients under judicial protection, tutorship or curatorship (for France only)
研究组 & 干预措施
BioFreedom™ Drug Coated Stent
Experimental
干预措施: BioFreedom™ Drug Coated Coronary Stent System (Device)
BioFreedom™ Drug Coated Stent
Experimental
干预措施: Antiplatelet Drug (Drug)
结局指标
主要结局
The incidence of clinically driven target lesion revascularization at twelve months
时间窗: 12 months
The composite of cardiac death and myocardial infarction at twelve months
时间窗: 12 months
次要结局
- Clinically driven target lesion revascularization at time points other than primary endpoint(followed for all target lesion revascularizations, up to 3 years)
- Urgent target lesion revascularization(1, 2, and 6 months and 1, 2, and 3 years)
- The composite of cardiac death and myocardial infarction(1, 2, and 6 months and 2 and 3 years)
- The incidence of clinically driven target lesion revascularization(1, 2, and 6 months and 2 and 3 years)
- Clinically driven target vessel revascularization(1, 2, and 6 months and 1, 2, and 3 years)
- Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter(1, 2, and 6 months and 1, 2, and 3 years)
- The composite of cardiac death, myocardial infarction and stent thrombosis(1, 2, and 6 months and 1, 2, and 3 years)
- Bleeding per Bleeding Academic Research Consortium (BARC) Criteria(1, 2, and 6 months and 1, 2, and 3 years)
- Cardiac Death(1, 2, and 6 months and 1, 2, and 3 years)
- Myocardial Infarction(1, 2, and 6 months and 1, 2, and 3 years)
- Stent Thrombosis per Academic Research Consortium (ARC) Definition(1, 2, and 6 months and 1, 2, and 3 years)
- All cause mortality(1, 2, and 6 months and 1, 2, and 3 years)
研究者
研究点 (66)
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