Multicenter, Randomized, Open and Controlled Study of Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,000
- 主要终点
- Late luminal loss (LLL)
研究概览
简要总结
The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.
详细描述
The main objective of this study is to compare a Drug-coated Ballon with Drug-eluting stent in the treatment of coronary arty lesions in STEMI patients in de novo coronary lesions.The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.
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
- •Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent
- •Angiographic criteria 1)In situ coronary artery disease 2)The reference diameter of the target vessel was 2.5-3.5 mm and the length was less than 28 mm 3)Visual examination showed that the diameter of lesions in criminals was narrower than or equal to 80%.
排除标准
- •1.Clinical criteria
- •Killip grading is greater than 3
- •Significant abnormalities in hemorrhagic quality or known coagulation function
- •History of intracranial tumors, aneurysms, arteriovenous malformations or cerebral hemorrhage;There was a history of stroke or TIA in 6 months and gastrointestinal bleeding in 2 months.Major operations were performed within 6 weeks.Recent or known platelets < 100,000/mm3 or hemoglobin < 10 g/dL.
- •Planned elective surgery may lead to early discontinuation of ADP receptor antagonists
- •The expected survival time of patients with other systemic diseases, such as malignant tumors is less than 1 year 2.Angiographic criteria
- •Left main lesion 2)The grade of dissection is greater than or equal to grade C lesions. 3)Coronary artery bridge lesions 4)In-stent restenosis 5)Severe stenosis of non-criminal lesions requiring selective treatment
研究组 & 干预措施
Drug-coated ballon
Treatment of in suit coronary lesions with drug-coated balloon
干预措施: Drug-coated balloon (Device)
Drug-eluting stent
Treatment of in suit coronary lesions with drug-eluting stent
干预措施: Drug-eluting stent (Device)
结局指标
主要结局
Late luminal loss (LLL)
时间窗: 9 months
LLL was the difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography
次要结局
- Target lesion failure (TLF)(12-24 months)
- Restenosis rate (RR)(12-24 months)
- Target lesion thrombosis(12-24 months)
- MACE(12-24 months)
研究者
Jian'an Wang,MD,PhD
President of Second Affiliated Hospital,School of Medicine,Zhejiang University &Chief of Cardiology
Second Affiliated Hospital, School of Medicine, Zhejiang University