Evaluating IBS Angel for treating pulmonary artery stenosis in children

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

This study is testing a new device called IBS Angel to see if it can safely help children with pulmonary artery stenosis feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 1 Year to 14 Years
• Sex: All
• Sponsor: Biotyx Medical (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 10 sites (Changsha and 9 other locations)
• Trial ID: NCT04973540 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of the Iron Bioresorbable Scaffold System (IBS Angel) in children aged 1 to 14 years with pulmonary artery stenosis. A total of 82 patients will receive the IBS Angel implantation and will be monitored for outcomes at 1, 3, 6, 12, and 24 months post-procedure. The study is designed as a prospective, multi-center, single-arm trial, focusing on patients with specific criteria related to the severity of their condition. The goal is to determine how well this innovative treatment can improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1 to 14 years with congenital or secondary pulmonary artery stenosis meeting specific severity criteria.

Not a fit: Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for managing pulmonary artery stenosis in pediatric patients.

How similar studies have performed: While this approach is innovative, similar studies evaluating bioresorbable scaffolds in other vascular conditions have shown promising results.

Eligibility criteria

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.
11. Patient who have already participated in another drug or medical device clinical trial that have not yet completed or withdrawn within 3 months before the screening period of this trial.
12. Patients who are not suitable for participating the trial as per investigator judgement.

Where this trial is running

Changsha and 9 other locations

• The Second Xiangya Hospital of Central South University — Changsha, China (Not_yet_recruiting)
• Children's Hospital of Chongqing Medical University — Chongqing, China (Not_yet_recruiting)
• The People's Hospital of Gaozhou — Gaozhou, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, China (Recruiting)
• Fuwai Yunnan Cardiovascular Hospital — Kunming, China (Not_yet_recruiting)
• Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• General Hospital of Northern Theater Command of Chinese People's Liberation Army — Shenyang, China (Not_yet_recruiting)
• Shenzhen Children's Hospital — Shenzhen, China (Not_yet_recruiting)
• Fuwai Central China Cardiovascular Hospital — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Ying Xia

Conditions Pulmonary Artery Stenosis