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
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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