Nit-Occlud PDA Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 11
- 主要终点
- Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety
研究概览
简要总结
The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographically confirmed PDA with minimum diameter < 4 mm.
- •Weight is ≥ 5 kg.
- •Age 6 months to 21 years.
排除标准
- •Cardiac anomalies requiring surgery.
- •Known bleeding or coagulation disorder.
- •Febrile illness within 7 days of planned procedure.
- •Pregnancy.
- •Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
- •Hypersensitivity to contrast medium.
- •Known nickel allergy.
结局指标
主要结局
Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety
时间窗: 24 months (2 year)
The primary safety endpoint is to demonstrate the 24-month serious device-related adverse event rate is no worse than the objective-performance criterion (OPC) of 1%.
Rate of Complete PDA Closure as a Measure of Efficacy
时间窗: 12 months (1 year)
The primary effectiveness endpoint is to demonstrate the 12-month (1 year) complete closure rate for the device is no worse than the OPC of 85%. The closure of the ductus arteriosus will be assessed by absence of residual flow at 12 months (1 year) by transthoracic echocardiogram with 2-D color flow mapping and pulse wave Doppler (ECHO).
次要结局
- Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety(24 months (2 year))