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

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

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

Official Title

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

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 Type

Interventional

Primary Outcome

Number of participants for surgical repair of CHD

Condition

Patent Ductus Arteriosus

Intervention

Iron biocorrodable coronary scaffold system

Study Arms / Comparison Groups

 IBS implantation
Description:  Implantation of IBS in PDA in duct-dependent cyanotic CHD

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

10

Start Date

December 11, 2018

Completion Date

August 2021

Primary Completion Date

August 2020

Eligibility Criteria

        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

Gender

All

Ages

N/A - 3 Months

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Malaysia

Location Countries

Malaysia

Administrative Informations

NCT ID

NCT04291222

Organization ID

IBS-AngelV1.0

Responsible Party

Sponsor

Study Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Study Sponsor

, ,

Verification Date

February 2020