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

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

NCT04973540•Biotyx Medical (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 14 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must between 1 and 14 years old.
•2. 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%.
•3. Patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up.
•4. Patients have life expectancy \>2 year after successful stent implantation.

Exclusion Criteria

•1. Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
•2. 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.
•3. Patients with known allergy to contrast agent, iron and its degradation products.
•4. Patients with hemorrhagic disorders.
•5. Patients with contraindications on antiplatelet agents and anticoagulant therapy.
•6. Patients with thrombosis at the vascular wall of target lesion or the distal or proximal location.
•7. Patients with known severe renal or hepatic insufficiency which are unsuitable for index procedure as per investigator judgement.
•8. Previous stent implantation has been performed to treat the target lesion;
•9. Patients with severe stenosis or excessive tortuosity in the targeted vessels, or anatomical abnormalities, making it difficult for device to reach the target lesion.
•10. Other conditions that are not suitable for stent delivery or balloon expansion.
+2 more criteria

Locations (10)

The Second Xiangya Hospital of Central South University

Changsha, China

Children's Hospital of Chongqing Medical University

Chongqing, China

The People's Hospital of Gaozhou

Gaozhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

Fuwai Yunnan Cardiovascular Hospital

Kunming, China

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Shenyang, China

Shenzhen Children's Hospital

Shenzhen, China

Fuwai Central China Cardiovascular Hospital

Zhengzhou, China

Key Dates

Start Date

July 13, 2021

Primary Completion Date

July 1, 2024

Completion Date

December 1, 2025

Last Updated

November 19, 2021

Enrollment

ESTIMATED participants

Conditions

Pulmonary Artery Stenosis

Interventions

Iron Bioresorbable Scaffold System (IBS Angel)

DEVICE

Contacts

Ying Xia

CONTACT

86 13760184511 xiaying@lifetechmed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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