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

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04291222
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus; Duct-dependent Cyanotic Congenital Heart Disease	Device: Iron biocorrodable coronary scaffold system	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group AssignmentSingle Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
• Actual Study Start Date: Dec 11, 2018
• Anticipated Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of participants for surgical repair of CHD [9 months]

   Patients are subjected for surgical repair of CHD

2. Number of Unplanned re-intervention [9 months]

   Unplanned re-intervention with additional stenting procedure

3. Death [9 months]

   Death before surgical repair

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 3 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jantung Negara	Kuala Lumpur		Malaysia

Sponsors and Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04291222
• Other Study ID Numbers: IBS-AngelV1.0
• First Posted: Mar 2, 2020
• Last Update Posted: Mar 2, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital; Ductus Arteriosus, Patent

Study Results

No Results Posted as of Mar 2, 2020