Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 598
- 试验地点
- 4
- 主要终点
- DoCE (Device-oriented composite endpoint)
研究概览
简要总结
The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI).
Randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.
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
- •Age >18 years with a life expectancy of >1 year;
- •Patients fulfilling criteria for STEMI (>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms)
- •Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.
排除标准
- •Killip class>II on admission
- •Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor
- •Previous myocardial infarction
- •Previous PCI in the territory of the infarct-related artery (IRA)
- •Previous CABG
- •3-vessel disease requiring revascularization
- •Left-main disease
- •Extremely angulated or severely calcified vessels
- •History of ischemic stroke within the past 6 months or hemorrhagic stroke
- •Planned CABG for a non-culprit vessel
- •Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study
研究组 & 干预措施
Drug coated balloon (DCB)
Drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2
干预措施: Drug (paclitaxel) coated balloon (DCB) (Device)
Second generation of drug eluting stents (DES)
Drug eluting stent (DES)
干预措施: Second-generation Drug Eluting Stent (DES) (Device)
结局指标
主要结局
DoCE (Device-oriented composite endpoint)
时间窗: 1 year and 2 years
DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).
次要结局
- Individual components of the primary endpoint (DoCE)(1 year and 2 years)
- Patient-oriented composite endpoint (PoCE)(1 year and 2 years)
- Target vessel revascularization (TVR)(1 year and 2 years)
- Target vessel failure (TVF)(1 year and 2 years)
- BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.(1 year and 2 years)
研究者
Mila Kovacevic
Assistant Professor, MD, PhD
University of Novi Sad