UnknownNot Applicable

Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD

Malaysia10 participantsStarted 2018-12-11

Plain-language summary

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.

Who can participate

Age range3 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants for surgical repair of CHD

Timeframe: 9 months

Number of Unplanned re-intervention

Timeframe: 9 months

Death

Timeframe: 9 months

Trial details

NCT IDNCT04291222

SponsorLifetech Scientific (Shenzhen) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08

View on ClinicalTrials.gov More Patent Ductus Arteriosus trials