Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- late lumen loss (LLL) at 7 months after procedure
研究概览
简要总结
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
详细描述
This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk.
All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will remain blinded until the final study results released.
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
- •De novo lesions, suitable for DCB treatment.
- •Patients with high bleeding risk.
排除标准
- •Target lesion length > 15mm.
- •Severe calcified lesions.
- •Left main disease.
- •Ostial lesions.
- •Three-vessel disease.
- •Acute myocardial infarction within 48 hours.
- •Target vessel received stent implantation.
- •Hemodynamic instability.
研究组 & 干预措施
IVUS-guided DCB
In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up.
干预措施: IVUS guidance (Device)
Angiography-guided DCB
In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography.
干预措施: Angiography guidance (Device)
结局指标
主要结局
late lumen loss (LLL) at 7 months after procedure
时间窗: 7 months
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up
次要结局
- Target vessel failure (TVF) at 6 months(6 months)
- bleeding at 6 months(6 months)
研究者
Junjie Zhang
Vice chief of the department of cardiology
Nanjing First Hospital, Nanjing Medical University