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

Biotyx Medical (Shenzhen) Co., Ltd.10 sites in 1 country82 target enrollmentJuly 13, 2021

ConditionsPulmonary Artery Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Artery Stenosis
Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.
Enrollment: 82
Locations: 10
Primary Endpoint: Rate of procedural success
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

July 13, 2021

End Date

December 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotyx Medical (Shenzhen) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must between 1 and 14 years old.
•Patients who have congenital or secondary pulmonary artery stenosis (including pulmonary artery trunk, left pulmonary artery and right pulmonary artery), and meeting one of the following criteria:
•A: The pressure gradient across the stenosis ≥20mmHg measured by catheter; B: The degree of pulmonary artery stenosis ≥50% ( calculated by (diameter of adjacent normal segments - residual lumen diameter of the stenosis segment)/diameter of adjacent normal segments ×100%); C: The ratio of right ventricular systolic pressure to aortic systolic pressure ≥50%.
•Patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up.
•Patients have life expectancy \>2 year after successful stent implantation.

Exclusion Criteria

•Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
•Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be controlled by active medical treatment.
•Patients with known allergy to contrast agent, iron and its degradation products.
•Patients with hemorrhagic disorders.
•Patients with contraindications on antiplatelet agents and anticoagulant therapy.
•Patients with thrombosis at the vascular wall of target lesion or the distal or proximal location.
•Patients with known severe renal or hepatic insufficiency which are unsuitable for index procedure as per investigator judgement.
•Previous stent implantation has been performed to treat the target lesion;
•Patients with severe stenosis or excessive tortuosity in the targeted vessels, or anatomical abnormalities, making it difficult for device to reach the target lesion.
•Other conditions that are not suitable for stent delivery or balloon expansion.