NCT05750771已完成不适用
Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease
Henan Institute of Cardiovascular Epidemiology1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2023年2月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- LLL
研究概览
简要总结
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.
And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. older than 60 years of age.
- •2. meeting the indications for coronary intervention.
- •3. IVUS examination suggests severe calcified lesions (calcification angle > 270° at the target lesion) ;
- •4. Target lesion vessel diameter > 2.75 mm
排除标准
- •1. inability to provide written informed consent.
- •2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
- •3. the subject is participating in another uncompleted clinical trial
- •4. life expectancy <1 year.
- •5. non-in situ vascular lesions.
- •6. cardiogenic shock.
- •7. Patients with hemodynamic instability
研究组 & 干预措施
DES Group
Experimental
Implantation of drug-eluting stents in patients with satisfactory pretreatment
干预措施: DES (Device)
DCB Group
Experimental
Implantation of drug-coated balloons in patients with satisfactory pretreatment
干预措施: DCB (Device)
结局指标
主要结局
LLL
时间窗: 12 months
Late lumen loss (LLL) of the target lesion segment
次要结局
- MACE(Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge)
研究者
研究点 (1)
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