Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- late lumen loss（LLL）
研究概览
简要总结
Objectives: The present study aimed to investigate the difference in late luminal loss (LLL) at 9-month after drug-coated balloon (DCB) treatment with intravascular ultrasound (IVUS) versus angiography for ST-segment elevated myocardial infarction （STEMI）patients.
Background: In primary percutaneous coronary intervention for STEMI, DCB angioplasty has proved to be a safe and feasible strategy. Compare with angiography guidance, IVUS-guided PCI significantly improve clinical outcome. With IVUS guidance, STEMI patients undergo DCB angioplasty might have be beneficial results.
Methods: A total of 208 STEMI patients who required DCB treatment were randomly assigned either an IVUS guidance and angiography guidance group. The primary endpoint was late luminal loss at 9-month. Stent thrombosis (ST) was the safety endpoint.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction eligible for PPCI:
- •>20 min of chest-pain and 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 complaints.
- •Infarct related artery eligible for PPCI and:
- •De novo lesion in a native coronary artery
- •Reference-vessel diameter 2.5 mm and 4 mm
- •Diameter stenosis of >50% (by visual assessment) after thrombus aspiration and pre-dilatation.
排除标准
- •- Age <18 yr and >85 yr
- •History of myocardial infarction
- •lesion length > 30m
- •Left Main lesion
- •Ostial lesion
- •None-target vessel need to treat with PCI
- •Severe calcification
- •Severe tortuosity
- •Severe angulation
- •Cardiogenic shock before pre-dilation or any serious cases can not perform IVUS
- •Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor
- •Participation in another clinical study, interfering with this protocol Uncertain
- •Known intracranial disease (mass, aneurysm, AVM, haemorrhagic CVA, ischemic CVA/TIA <6 months before inclusion or ischemic CVA with permanent neurological deficit) Gastrointestinal/urinary tract
- •bleeding <2 months before inclusion Refusal to receive blood transfusion
- •Planned major surgery within 6 weeks
- •Stent implantation <1 week before inclusion
- •Expected mortality from any cause within the next 12 months
结局指标
主要结局
late lumen loss（LLL）
时间窗: At 9 months follow-up
late lumen loss（LLL）
次要结局
- target lesion failure (TLF)(At 1-year follow-up)