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

Pulmonary Artery Stenosis Clinical Trial

— IRIS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04973540
• Other study ID #: IBS Angel-01
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: December 2025

Study information

• Verified date: November 2021
• Source: Biotyx Medical (Shenzhen) Co., Ltd.
• Contact: Ying Xia
• Phone: 86 13760184511
• Email: xiaying[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Pulmonary Artery Stenosis

Intervention

Device:
• Iron Bioresorbable Scaffold System (IBS Angel)
Subjects in this arm will be implanted with IBS Angel.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Biotyx Medical (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of freedom from in-stent restenosis	Defined on a per target lesion basis.	12 months
Primary	Rate of procedural success	Defined on a per target lesion basis.	Immediately post-procedure
Secondary	Rate of technical success	Defined on a per target lesion basis.	Immediately post-procedure
Secondary	Rate of freedom from in-stent restenosis	Defined on a per target lesion basis.	1 month
Secondary	Rate of freedom from in-stent restenosis	Defined on a per target lesion basis.	3 months
Secondary	Rate of freedom from in-stent restenosis	Defined on a per target lesion basis.	6 months
Secondary	Rate of device-related adverse events		1 month
Secondary	Rate of device-related serious adverse events		1 month
Secondary	Rate of device-related adverse events		3 months
Secondary	Rate of device-related serious adverse events		3 months
Secondary	Rate of device-related adverse events		6 months
Secondary	Rate of device-related serious adverse events		6 months
Secondary	Rate of device-related adverse events		12 months
Secondary	Rate of device-related serious adverse events		12 months
Secondary	Rate of device-related adverse events		24 months
Secondary	Rate of device-related serious adverse events		24 months
Secondary	Rate of unplanned surgery or re-intervention		1 month
Secondary	Rate of unplanned surgery or re-intervention		3 months
Secondary	Rate of unplanned surgery or re-intervention		6 months
Secondary	Rate of unplanned surgery or re-intervention		12 months
Secondary	Rate of unplanned surgery or re-intervention		24 months
Secondary	Rate of stent thrombosis		1 month
Secondary	Rate of stent thrombosis		3 months
Secondary	Rate of stent thrombosis		6 months
Secondary	Rate of stent thrombosis		12 months
Secondary	Rate of stent thrombosis		24 months
Secondary	Rate of all-cause death		1 month
Secondary	Rate of all-cause death		3 months
Secondary	Rate of all-cause death		6 months
Secondary	Rate of all-cause death		12 months
Secondary	Rate of all-cause death		24 months
Secondary	Rate of stent displacement		1 month
Secondary	Rate of stent displacement		3 months
Secondary	Rate of stent displacement		6 months
Secondary	Rate of stent displacement		12 months
Secondary	Rate of adverse events		1 month
Secondary	Rate of serious adverse events		1 month
Secondary	Rate of adverse events		3 months
Secondary	Rate of serious adverse events		3 months
Secondary	Rate of adverse events		6 months
Secondary	Rate of serious adverse events		6 months
Secondary	Rate of adverse events		12 months
Secondary	Rate of serious adverse events		12 months
Secondary	Rate of adverse events		24 months
Secondary	Rate of serious adverse events		24 months
Secondary	Rate of device deficiency		Day 0