NCT05549440招募中不适用
BIOTRONIK- A Prospective, Randomised, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to Resolute Onyx Stent in Subjects at High Risk of Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of Major Adverse Cardiovascular Event (MACE) 12 months post-operation
研究概览
简要总结
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomised controlled clinical study. A total of 1,948 subjects will be randomised 1:1 to receive either Orsiro or Resolute onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subject is acceptable candidate for treatment with a DES
- •Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment:
- •>=75 years of age
- •Moderate (estimated GFR 30-59ml/min) or severe (estimated GFR <= 30ml/min) chronic kidney disease or failure (dialysis dependent)
- •Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices
- •Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated
- •Anemia with haemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomisation
- •baseline thrombocytopenia defined as a platelet count < 100,000/mm
- •History of stroke (ischemic or haemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenus malformation
- •history of hospitalisation for bleeding within the past 12 months
- •Chronic clinically significant bleeding diathesis
- •Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)
- •clinically indication for chronic or lifelong steroid or oral non-steroidal anti-inflammation drug(s) (NSAIDs), other than aspirin
- •Nondeferrable major surgery on DAPT
- •Recent major surgery or trauma within 30 days before PCI
- •PRECISE DAPT score >= 25
- •Subject is >=18 years or the minimum age required for legal adult consent in the country of enrollment
- •Subject is capable ( no legally authorised representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site prior to any study related procedure.
- •Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month.
- •Subject is eligible for dual antiplatelet therapy treatment with aspiring plus a P2Y12 inhibitor agent for 1-month post index procedure
排除标准
- •Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel
- •Subject has a known allergy to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel, molybdenum, platinum and iridium, silicon carbide, PLLA, polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
- •Revascularisation of any target vessel within 9 months prior to the index procedure
- •Subject with documented left ventricular ejaculation fraction (LVEF) < 30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.), but within 90 days pre/procedure or during the index procedure.
- •Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT
- •Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor and/or aspirin within the first month post-index procedure. Note - planned staged procedure at the time of index procedure is not allowed
- •Active bleeding at the time of inclusion
- •Subject with a current medical condition with a life expectancy of less than 12 months
- •Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following index procedure or any other clinical trial that may interfere with the treatment or protocol of this study
- •Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
- •In the investigator' opinion, subject will not be able to comply with the follow-up requirements
- •Subjects who needs an impartial witness to give an informed consent
结局指标
主要结局
Rate of Major Adverse Cardiovascular Event (MACE) 12 months post-operation
时间窗: 12 months
The composite of cardiac death, myocardiac infraction (MI) and definite or probable stent thrombosis at 12 months post-index procedure
次要结局
- Rate of Revascularisation(12 months)
- Death rate(12 months)
- Device success rate(12 months)
- Rate of Major Adverse Cerebral &Cardiovascular Event (MACCE)(12 months)
- Rate of tricuspid valve replacement (TVR)(12 months)
- rate of Target vessel failure(12 months)
- Procedure success rate(12 months)
- Rate of stent thrombosis (ST)(12 months)
- Rate of Target lesion failure(12 months)
- Rate of bleeding(12 months)
研究者
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong
研究点 (2)
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