NCT00180583已完成4 期
Vision II: Non Randomized French Evaluation of GALILEO Intravascular Radiotherapy System in Patients With de Novo Coronary Arteries Lesions by Restenosis on Angioplasty or Restenosis on Endoprosthesis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system
详细描述
The purpose of this study is to evaluate the cardiac events (MACE) and adverse extra cardiac events at 6 month follow up and up to 24 months for the patients treated with Galileo system
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient with angor, patients with only one de novo lesion. Target zone must be < 52 mm, artery section must be < 3,7mm and > 2,25 mm
排除标准
- •Vessel with extremely tortuous proximal segment, lesion with angulous segments (>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc...
结局指标
主要结局
MACE
时间窗: 6 months
次要结局
- All adverse cardiac or extra cardiac events(24-month)
研究者
研究点 (1)
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