NCT04291222

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Ductus Arteriosus
• Duct-dependent Cyanotic Congenital Heart Disease

Interventions

Type	Name	Description
DEVICE	Iron biocorrodable coronary scaffold system	Implantation of Iron biocorrodable coronary scaffold system

Timeline

• Start date: 2018-12-11
• Primary completion: 2020-08-01
• Completion: 2021-08-01
• First posted: 2020-03-02
• Last updated: 2020-03-02

Locations

1 site across 1 country: Malaysia