A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis

  • STATUS
    Recruiting
  • End date
    Dec 25, 2025
  • participants needed
    82
  • sponsor
    Biotyx Medical (Shenzhen) Co., Ltd.
Updated on 25 November 2021

Summary

This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.

Description

82 patients with pulmonary artery stenosis will be treated with the Iron Bioresorbable Scaffold System (IBS Angel) developed by Biotyx Medical (Shenzhen) Co., Ltd. This study is designed as a prospective, multi-center, single-arm clinical trial. Enrolled patients will undergo IBS Angel implantation and will be followed up at 1, 3, 6, 12, and 24 months post-procedure.

Details
Condition Pulmonary Artery Stenosis
Treatment Iron Bioresorbable Scaffold System (IBS Angel)
Clinical Study IdentifierNCT04973540
SponsorBiotyx Medical (Shenzhen) Co., Ltd.
Last Modified on25 November 2021

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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