NCT05101005Unknown不适用
A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Target lesion failure
研究概览
简要总结
To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).
详细描述
Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. 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, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.
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, regardless of gender;
- •De novo lesion in a native coronary artery;
- •Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
- •Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
- •The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
- •The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up.
排除标准
- •Reference vessel diameter <2.75 mm or >4.0 mm;
- •In stent restenosis;
- •Left main lesion, chronic complete occlusion lesion;
- •Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
- •There is a large scale of thrombus in the target vessel, and the thrombus grade >3 after thrombolysis or aspiration;
- •Severe heart failure (NYHA IV);
- •Severe renal failure (GFR<30ml/min) or undergoing hemodialysis treatment;
- •Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal);
- •Patients with vein graft restenosis after bypass or severe heart valve disease;
- •Pregnant or breastfeeding female patients;
- •The life expectancy of the patient is less than 12 months;
- •The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications;
- •Anemia (women's hemoglobin <117g/L, or men's hemoglobin <134g/L), or thrombocytopenia detected before the intervention within 6 months (<100×10⁹/L);
- •Planned to perform non-cardiac surgery within 12 months after index procedure;
- •The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint;
- •Heart transplant patients;
- •Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel;
- •The investigator judged that the patient had poor compliance and could not complete the study as required.
结局指标
主要结局
Target lesion failure
时间窗: 12 months follow-up
A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization
次要结局
- Procedural success(During the hospital stay, up to 7 days after PCI)
- Patient-oriented composite endpoint(1 month, 6months,12 months follow-up)
- Target lesion failure(1 month, 6months follow-up)
研究者
相似试验
招募中
不适用
DCB vs. DES in Bifurcation Coronary LesionsDCBCoronary Artery DiseaseNCT06551662Fondazione Ricerca e Innovazione Cardiovascolare ETS321
Unknown
不适用
DCB Compared Stenting in Popliteal LesionsPopliteal StenosisPopliteal Artery OcclusionDiabetesNCT03739580Xuanwu Hospital, Beijing80
终止
不适用
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk AngioplastyHigh Bleeding RiskCoronary Artery Disease (CAD)Percutaneous Coronary Intervention (PCI)NCT04885816Instituto Nacional de Cardiologia Ignacio Chavez5
招募中
不适用
ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent RestenosisIntracranial AtherosclerosisStrokeNCT04627870Acotec Scientific Co., Ltd20
招募中
不适用
Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients with High Bleeding RiskDiseases of the circulatory systemKCT0006983Samsung Medical Center1,350