NCT01479218已完成不适用
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.
研究概览
简要总结
The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a demonstrated patent ductus arteriosus
- •Female or male
- •Belonging to any ethnic group
- •Age between > 6 months and 70 years
- •Body weight > 6 kg < 120 kg
排除标准
- •Associated congenital cardiac anomalies,
- •Body weight < 6 Kilograms
- •General exclusion criteria
- •presence of a known coagulation disorder
- •thrombus at the position allocated for the implantation
- •a vein thrombosis in the blood vessels chosen for the introducing system
- •an active infection
- •Nitinol intolerance (nickel or titanium)
- •contrast medium intolerance
- •patients who have a vascular system which is too small to admit the required sheath
- •patients with pulmonary hypertension and pulmonary-vascular resistance of >8 Woods Units or a lung - / systemic resistance (PR/SR) of >0.4.
研究组 & 干预措施
PDA Occluder
Other
single arm
干预措施: Occlutech PDA occluder (Device)
结局指标
主要结局
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.
时间窗: 3 months
次要结局
- Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits.(30, 90, 180 and 360 days after implant)
研究者
研究点 (2)
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