Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS): A Prospective, Multi-Center, Randomized-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Fractional flow reserve (FFR)
研究概览
简要总结
The DCB-ACS trial is a prospective, multi-center, non-inferiority, randomized controlled trail. The purpose of this trial is to evaluate the safety and efficacy of drug-coated balloon(DCB) in de novo lesions for acute coronary syndromes (ACS) .
详细描述
Patients with ACS and indications for percutaneous coronary intervention were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a Zotarolimus-Eluting Coronary Stent(ZES) . Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, 12 months, and 24 months after discharge, and coronary angiography and FFR measurements will be carried out at 9 months.The primary objective is to show non-inferiority of DCB versus drug-eluting stent(DES) regarding the functional assessment of target lesion by FFR at 9 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 Years and <80 years;
- •ACS patients eligible for percutaneous coronary intervention;
- •Successful preparation is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of type C-F dissection;
- •Vessel diameter from 2.25mm-4.0 mm ;
- •Lesion length ≤ 28 mm;
- •A single culprit lesion or 1 lesion in each of two vessels ;
- •Eligible for enrollment and provide written informed consent.
排除标准
- •Clinical Exclusion Criteria：
- •Stable angina or asymptomatic myocardial ischemia;
- •Cardiogenic shock or requiring mechanical support for breathing and circulation;
- •Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
- •Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
- •A history of stroke within 6 months;
- •History of severe renal insufficiency;
- •Life expectancy < 12 months;
- •Pregnant women;
- •Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;
- •Patients not suitable for enrollment considered by researcher;
- •Currently participating in another trial before reaching the primary endpoint;
- •Inability to provide informed consent. Image Exclusion Criteria
- •1. Chronic total occlusion (CTO);
- •Left main lesion;
- •Bifurcation lesions treated with double stents;
- •Moderate to severe distortion, angulation or severe calcification lesions;
- •Coronary artery graft stenosis;
- •In-stent restenosis;
- •To be re-hospitalized for the other scheduled PCI treatment;
- •Myocardial bridge at the target lesion.
结局指标
主要结局
Fractional flow reserve (FFR)
时间窗: 9 months follow-up
Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.
次要结局
- Target lesion failure（TLF）(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Target vessel-related myocardial infarction(12 months, 24 months follow-up)
- Major bleeding(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Procedure success(1 month)
- Revascularization of target lesion revascularization (TLR)(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Restenosis rate of target lesion(9 months)
- Cardiac death(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- All-cause death and myocardial infarction(1 month, 6 months, 9 months, 12 months, 24 months follow-up)
- Diameter stenosis(DS%)(9 months follow-up)
- Rehospitalized due to angina(2 years)
- Patient-oriented composite endpoint (PoCE)(1 month, 6 months, 9 months, 12 months ,24 months follow-up)
- Late lumen loss (LLL）(9 months follow-up)
- Definite and possible thrombotic events(2 years)
- Stroke(2 years)
研究者
Yu Bo
The Head of cardiology department
The Second Affiliated Hospital of Harbin Medical University