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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-11

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patent Ductus Arteriosus Duct-dependent Cyanotic Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBS implantation

Implantation of IBS in PDA in duct-dependent cyanotic CHD

Group Type EXPERIMENTAL

Iron biocorrodable coronary scaffold system

Intervention Type DEVICE

Implantation of Iron biocorrodable coronary scaffold system

Interventions

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Iron biocorrodable coronary scaffold system

Implantation of Iron biocorrodable coronary scaffold system

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No