NCT04137510已完成4 期
A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 1,948
- 试验地点
- 104
- 主要终点
- Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months
研究概览
简要总结
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.
A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission 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.
Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.
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
- None
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
- •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 30-59 ml/min) or severe (estimated GFR < 30 ml/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 hemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization
- •Baseline thrombocytopenia defined as a platelet count <100,000/mm3
- •History of stroke (ischemic or hemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenous malformation
- •History of hospitalization for bleeding within the previous 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)
- •Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin
- •Nondeferrable major surgery on DAPT
- •Recent major surgery or major 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 authorized 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 aspirin 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 irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
- •Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 72 hours prior to or during the index procedure
- •Subject with documented left ventricular ejection 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 the 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's opinion, subject will not be able to comply with the follow-up requirements
- •Subjects who need an impartial witness to give an informed consent
结局指标
主要结局
Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months
时间窗: 12 months post-procedure
次要结局
- Rate of MACE(until 12 months post-procedure)
- Rate of cardiac death or MI(until 12 months post-procedure)
- Rate of all-cause death, cardiac, non-cardiac(until 12 months post-procedure)
- Rate of clinically-indicated TVR(until 12 months post-procedure)
- Rate of Target Vessel Failure (TVF)(until 12 months post-procedure)
- Rate of bleeding according to BARC definition(until 12 months post-procedure)
- Rate of definite/probable stent thrombosis according to the ARC definition(until 12 months post-procedure)
- Rate of stroke, ischemic and hemorrhagic(until 12 months post-procedure)
- Rate of clinically-indicated Target Lesion Revascularization (TLR)(until 12 months post-procedure)
- Rate of target lesion failure (TLF)(until 12 months post-procedure)
- Rate of bleeding according to TIMI definition(until 12 months post-procedure)
- Rate of Device success(until 12 months post-procedure)
- Rate of bleeding according to GUSTO definition(until 12 months post-procedure)
- Rate of MACCE(until 12 months post-procedure)
- Rate of Procedure success(until 12 months post-procedure)
研究者
研究点 (104)
Loading locations...
相似试验
招募中
不适用
BIOFLOW-Dual Anti-Platelet TherapyPercutaneous InterventionNCT05549440Chinese University of Hong Kong50
已完成
4 期
The Dual Antiplatelet Therapy Study (DAPT Study)Coronary Artery DiseaseNCT00977938Baim Institute for Clinical Research25,682
Unknown
不适用
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting StentCoronary Artery DiseaseNCT01939249Biotronik AG585
招募中
不适用
Coronary Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis(CREST)Coronary Artery StenosisNCT05606367Shanghai MicroPort Rhythm MedTech Co., Ltd.200
Unknown
不适用
Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical StudyAntineoplastic AgentsCoronary Artery DiseaseNCT03284255Shanghai Bio-heart Biological Technology Co., Ltd.431