The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)
试验速览
- 阶段
- 4 期
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Late loss
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
详细描述
Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis.
DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length < 25 mm)
- •Informed consent
排除标准
- •Chronic total obstruction lesion
- •Severe calcified lesion
- •Left main coronary lesion
- •Lesion having intravascular thrombus
- •Shock status from any cause including cardiogenic shock
- •Left ventricular ejection fraction < 30%
- •Need for coronary artery bypass surgery
- •Allergic reaction for paclitaxel
- •Severe allergic for contrast agent (Visipaque) or statin
- •Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age
结局指标
主要结局
Late loss
时间窗: 9±1 months
Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary
Binary restenosis rate
时间窗: 9±1 months
Restenosis rate of the target lesion at the follow-up quantitative coronary angiography
次要结局
- Neointimal hyperplasia(9±1 months)
- Clinical outcomes(9±1 months)
研究者
Woong Chol Kang
Associate Professor
Gachon University Gil Medical Center