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

Pulmonary Artery Stenosis Clinical Trial

Official title:
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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04973540
Study type	Interventional
Source	Biotyx Medical (Shenzhen) Co., Ltd.
Contact	Ying Xia
Phone	86 13760184511
Email	xiaying@lifetechmed.com
Status	Recruiting
Phase	N/A
Start date	July 13, 2021
Completion date	December 2025

View Details

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