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

Not Applicable

• Conditions: Duct-dependent Cyanotic Congenital Heart Disease; Patent Ductus Arteriosus
• Interventions: Device: Iron biocorrodable coronary scaffold system

• Registration Number: NCT04291222
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Timeline

• Study Start: 2018-12-11
• Status Verified: 2020-02
• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Last Update Submitted: 2020-02-28
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02
• Primary Completion: 2020-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Weight >3.0 kg
• Age <3 months
• Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBS implantation	Iron biocorrodable coronary scaffold system	Implantation of IBS in PDA in duct-dependent cyanotic CHD

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Jantung Negara; 🇲🇾 Kuala Lumpur, Malaysia