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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Implantation of Iron biocorrodable coronary scaffold system
Institut Jantung Negara
Kuala Lumpur, Malaysia
Number of participants for surgical repair of CHD
Patients are subjected for surgical repair of CHD
Time frame: 9 months
Number of Unplanned re-intervention
Unplanned re-intervention with additional stenting procedure
Time frame: 9 months
Death
Death before surgical repair
Time frame: 9 months
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