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

February 28, 2020 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IBS implantation
Implantation of IBS in PDA in duct-dependent cyanotic CHD
Device: Iron biocorrodable coronary scaffold system
Implantation of Iron biocorrodable coronary scaffold system

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 11, 2018

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

February 28, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (ACTUAL)

March 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBS-AngelV1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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