NCT02348021Unknown3 期
BF-14J01 Drug Coated Stent (DCS) Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
研究概览
简要总结
Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.
详细描述
In this study all patients will receive the a Drug Coated Stent and will receive one month 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 PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (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 enrollment)
- •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
- •Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI
- •Planned surgery that would require interruption of DAPT (within next 12 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 30 days 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 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 other P2Y12 inhibitor (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 < 1 year
研究组 & 干预措施
Drug Coated Stent
Other
All patients in the one arm will be treated by PCI with the Drug Coated Stent.
干预措施: Percutaneous coronary intervention (PCI) (Procedure)
Drug Coated Stent
Other
All patients in the one arm will be treated by PCI with the Drug Coated Stent.
干预措施: Dual Anti Platelet Therapy (Drug)
结局指标
主要结局
The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis.
时间窗: 1 year
The number of patients that experienced a clinically driven target lesion revascularization
时间窗: 1 year
次要结局
- The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis(2 years)
- The number of patients that experienced a clinically driven target lesion revascularization(2 years)
- The number of patients that experienced a Bleeding per BARC criteria(30, 60 and 120 days, and 12 and 24 months)
- The number of patients that experienced a cardiac death(30, 60 and 120 days, and 12 and 24 months)
- The number of patients that experienced a definite/probable stent thrombosis.(30, 60 and 120 days, and 12 and 24 months)
- The number of patients that experienced a myocardial infarction(30, 60 and 120 days, and 12 and 24 months)
研究者
研究点 (1)
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