Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 357
- 试验地点
- 30
- 主要终点
- Objective Performance Criteria (OPC) Technical Success at Implant
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.
详细描述
The purpose of this clinical investigation is to evaluate whether transcatheter occlusion of PDAs with a minimum vessel diameter of 4 mm or smaller, by means of permanent implantation of the Nit-Occlud Spiral Coil for PDA Occlusion, is safe and effective.
The device used for this purpose is a set of two items named "Nit-Occlud - PDA Occlusion System":
- Nit-Occlud coils, 2 types: flexible (3 sizes) and medium (3 sizes)
- Introducer Sheath, F4 or F5 85cm.
The intended use of the device is the percutaneous, transluminal closure of PDA with an internal diameter or 4mm and smaller in patients who comply with the selection criteria.
The investigation will continue until the sponsor receives FDA approval for commercial distribution and implantation of the system, or until the project is terminated by the sponsor or by the investigators.
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
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PDA with 4 mm or smaller minimum diameter by color Doppler
- •Patent weight > 5 Kg, Age 6 months to 21 years (Patients older than 21 years may have device implant and be included in a study registry.)
- •Previous treatment by surgery or Nit-Occlud device with residual PDA noted at least 6 months after the procedure
- •Angiographic minimum PDA diameter (D1) less than 4 mm. (Patients with angiographic diameters larger than 4 mm and smaller or equal to 5 mm may have device implant and be included in a study registry.)
排除标准
- •Associated cardiac anomalies requiring surgery
- •Known bleeding or blood clotting disorders
- •Ongoing febrile illness
- •Pregnancy
- •Pulmonary hypertension/increased pulmonary vascular resistance (>5 Wood Units)
- •Known hypersensitivity to contrast medium
研究组 & 干预措施
Transcatheter PDA Coil
Transcatheter occlusion of Patent Ductus Arteriosus (PDA) with the flex and medium Nit-Occlud PDA.
干预措施: Transcatheter PDA Coil (Device)
结局指标
主要结局
Objective Performance Criteria (OPC) Technical Success at Implant
时间窗: One year
Total Device or Procedure Related Adverse Events
时间窗: One year
Clinical Closure and Echocardiographic Closure at 12 month follow-up
时间窗: One year
Serious Adverse Events and Mortality at 12 months
时间窗: One year
次要结局
- Composite Success. That is technical success, clinical and echocardiographic closure, and absence of device or procedure related death or serious AE at 12 months follow-up(One year)