Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
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About
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.
Full description
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.
Enrollment
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Ages
Volunteers
Inclusion criteria
- Weight >3.0 kg
- Age <3 months
- Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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