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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04291222

Enrollment

Registered

2020-03-02

Start date

2018-12-11

Completion date

2021-08-31

Last updated

2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duct-dependent Cyanotic Congenital Heart Disease, Patent Ductus Arteriosus

Brief 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.

Detailed 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.

Interventions

DEVICEIron biocorrodable coronary scaffold system

Implantation of Iron biocorrodable coronary scaffold system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

Healthy 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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants for surgical repair of CHD	9 months	Patients are subjected for surgical repair of CHD
Number of Unplanned re-intervention	9 months	Unplanned re-intervention with additional stenting procedure
Death	9 months	Death before surgical repair

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026