NCT04276389Unknown不适用
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study
Beijing Anzhen Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Late lumen loss
研究概览
简要总结
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years old
- •Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, or silent ischemia.
- •Reference vessel diameter >2.5 mm, and <4.0 mm.
- •Lesion length of <22 mm
- •Written informed consent
排除标准
- •Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
- •Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip≥3)
- •Chronic kidney disease (eGFR <30 ml/min)
- •Lesion length >22 mm, or vessel diameters of <2.5 mm or >4.0 mm
- •Stents covering a major side branch (>2 mm)
- •Left main lesion
- •Graft lesion
- •Aortic-coronary ostial lesion
- •In-stent restenotic lesion
- •Chronic total occlusion
- •Severe calcified lesions.
- •Visible angiographic thrombus
- •Severe comorbidities: eg. malignancy (life expectancy <2 years)
结局指标
主要结局
Late lumen loss
时间窗: 9 months
Evaluated by QCA
次要结局
- Rate of binary restenosis(9 months)
- Target lesion failure(9 months)
研究者
Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Beijing Anzhen Hospital
研究点 (2)
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