NCT03118895已完成不适用
A Study Evaluating the Safety and Efficacy of the BioFreedom™ Biolimus A9™ Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 2
- 主要终点
- MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)
研究概览
简要总结
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
详细描述
Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 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
盲法说明
370 high bleeding risk items
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of 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 inclusion into the trial)
- •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 1 month DAPT
- •Patients requiring a planned staged PCI procedure more than one week after the index procedure
- •Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
- •Active bleeding at the time of inclusion
- •If patient requires a stent <2.5mm
- •If patient requires a stent >3.5mm
- •Cardiogenic shock
- •Compliance with long-term single anti-platelet therapy unlikely
- •Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM 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
- •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
Treatment Arm
Experimental
Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent
干预措施: BioFreedom™ BA9™ drug-coated stent (Device)
结局指标
主要结局
MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)
时间窗: at 1 year
Incidence
clinically driven target lesion revascularization (efficacy)
时间窗: at 1 year
incidence
次要结局
- All-cause mortality(At 1 and 4 months, and 1 and 2 years)
- Clinically Driven Target Vessel Revascularization(At 1 and 4 months, and 2 years)
- Clinically Driven Target Lesion Revascularization(At 1 and 4 months, and 2 years)
研究者
研究点 (2)
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