Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants for surgical repair of CHD
研究概览
简要总结
This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the PDA as initial palliation of cyanotic CHD with duct-dependent PBF.
详细描述
Study type: Interventional, prospective, single arm, investigator initiated Study population: 10 patients Primary purpose: Treatment Follow up: Review at 1 month and thereafter 3 monthly (clinical examination and echocardiography for stent patency, SaO2 measurement. Serum Iron and Ferritin levels will be measured before procedure and at follow ups. From 6 months onwards the patients will be assessed for the need of repeat catheterization with a view of surgery or for continued observation.
Study endpoints: 9 months post implant or the following: 1)Patients are subjected for surgical repair of CHD; 2)Death before surgical repair; 3)Unplanned re-intervention with additional stenting procedure.
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
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight >3.0 kg
- •Age <3 months
- •Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight
排除标准
- •Weight <3 kg, age >3 months
- •Angiographic criteria-tortuous PDA
- •Family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis
- •Other severe congenital anomalies with life expectancy <12 months
结局指标
主要结局
Number of participants for surgical repair of CHD
时间窗: 9 months
Patients are subjected for surgical repair of CHD
Number of Unplanned re-intervention
时间窗: 9 months
Unplanned re-intervention with additional stenting procedure
Death
时间窗: 9 months
Death before surgical repair
次要结局
未报告次要终点