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NCT04291222 Clinical Trial

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

Patent Ductus Arteriosus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04291222
Other study ID # IBS-AngelV1.0
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 11, 2018
Est. completion date August 2021

Study information
Verified date February 2020
Source Lifetech Scientific (Shenzhen) Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date August 2021
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Iron biocorrodable coronary scaffold system
Implantation of Iron biocorrodable coronary scaffold system

Locations
Country Name City State
Malaysia Institut Jantung Negara Kuala Lumpur

Sponsors (1)
Lead Sponsor Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants for surgical repair of CHD Patients are subjected for surgical repair of CHD 9 months
Primary Number of Unplanned re-intervention Unplanned re-intervention with additional stenting procedure 9 months
Primary Death Death before surgical repair 9 months
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