NCT03589157Unknown不适用
Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial
Chinese PLA General Hospital0 个研究点目标入组 140 人开始时间: 2018年7月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 主要终点
- Late lumen loss
研究概览
简要总结
The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.
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
- Double (Participant, Care Provider)
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
- •Patient-related
- •Patients who have typical angina pectoris symptoms with obvious evidence of ischemia;
- •Patients whose ages are between 18-80 years;
- •Patients who must agree to receive a 9-month angiographic follow-up;
- •Patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months;
- •Patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol;
- •Patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent;
- •Lesion-related
- •Diffuse coronary artery disease in situ;
- •Reference target vessel diameter of 2.5-4.0 mm and length of > 25 mm;
- •Non-target vessel lesions needing to receive a successful intervention therapy first before randomization to receive treatment for target lesions (note: within the same hospitalization);
- •Visually estimated diameter stenosis of ≥70%, or diameter stenosis of ≥50% with objective evidences of ischemia (treadmill exercise testing, ECT or FFR<0.8)
排除标准
- •Patient-related:
- •Patients who have the attack of myocardial infarction within the past week, or whose troponin fails to return to normal although myocardial infarction has occurred for over one week;
- •Patients with serious congestive heart failure or NYHA IV-level serious heart failure;
- •Patients whose left ventricular ejection fraction is < 30%;
- •Patients who have medical history of stroke or TIA within 6 months prior to the surgery;
- •Patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography;
- •Patients who have a current or previous history of serious kidney failure (GFR<30 ml/min) and thereby fail to meet the requirements of angiography;
- •Patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage;
- •Patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically;
- •Patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of ADP receptor antagonists;
- •Pregnant or lactating women or women who are planning to become pregnant during the study.
- •Patients participating in any other clinical trial;
- •Patients who are considered not suitable for inclusion by the investigator for any other reason;
- •Lesion-related:
- •Patients who have the evidence of extensive thrombosis in target vessels prior to the interventional therapy;
- •Patients who have left main coronary artery disease or graft lesions needing to be treated;
- •Patients who have bifurcation lesions with a side-branch vessel diameter of >2.5 mm;
- •Patients who have lesions at the ostia of coronary artery, at the circumflex branch, at the ostia of anterior descending branch or within 5 mm at the ostia of coronary artery;
- •Severe intimal tear disease;
- •In-stent restenosis;
- •Lesions which can not be treated with PTCA or other intervention technologies;
- •Lesions with serious calcification;
- •Concomitant medication related
- •Patients who have a physique prone to hemorrhage and are prohibited from taking anticoagulants or antiplatelet drugs;
- •Patients who can not tolerate Aspirin and/or Clopidogrel, or who have serious hypohepatia and must not use Clopidogrel;
- •Patients who can not tolerate or have known allergy to heparin, contrast media, paclitaxel, iopromide, rapamycin, poly(lactic-co-glycolic acid) polymers or stainless steel, etc,;
- •Patients with a history of leukopenia (with WBC<3×109/L for more than 3 days), neutropenia (with ANC <1,000 cells/mm3 for more than 3 days), or thrombocytopenia (with platelet count <100,000/mm3);
研究组 & 干预措施
Drug-coated balloon group
Experimental
干预措施: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) (Device)
second-generation drug-eluting stent group
Active Comparator
干预措施: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES) (Device)
结局指标
主要结局
Late lumen loss
时间窗: 9 months
Late lumen loss (LLL) in the lesion segment within 9 months after surgery
次要结局
- Interventional therapy success rate(3 years)
- Clinically-driven target lesion revascularization(3 years)
- Device-related cardiovascular clinical composite endpoints(3 years)
- Patient-related cardiovascular clinical composite endpoints(3 years)
- Restenosis rate (RR) in the lesion segment(9 months)
研究者
Yun Dai Chen
Professor
Chinese PLA General Hospital
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