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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Artery Stenosis
• Intervention / Treatment: Device: Iron Bioresorbable Scaffold System (IBS Angel)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Changsha, China
    • Not yet recruiting
    • The Second Xiangya Hospital of Central South University
    • Principal Investigator: Zhenfei Fang
  • Chongqing, China
    • Not yet recruiting
    • Children's Hospital of Chongqing Medical University
    • Principal Investigator: Qijian Yi
  • Gaozhou, China
    • Recruiting
    • The People's Hospital of Gaozhou
    • Principal Investigator: Lian Hu
  • Guangzhou, China
    • Recruiting
    • Guangdong Provincial People's Hospital
    • Principal Investigator: Zhiwei Zhang
  • Kunming, China
    • Not yet recruiting
    • Fuwai Yunnan Cardiovascular Hospital
  • Shanghai, 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
    • Principal Investigator: Sun Chen
  • Shenyang, China
    • Not yet recruiting
    • General Hospital of Northern Theater Command of Chinese People's Liberation Army
    • Principal Investigator: Qiguang Wang
  • Shenzhen, China
    • Not yet recruiting
    • Shenzhen Children's Hospital
    • Principal Investigator: Boning Li
  • Zhengzhou, China
    • Not yet recruiting
    • Fuwai Central China Cardiovascular Hospital
    • Principal Investigator: Taibing Fan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IBS Angel; Iron Bioresorbable Scaffold System	Device: Iron Bioresorbable Scaffold System (IBS Angel); Subjects in this arm will be implanted with IBS Angel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of freedom from in-stent restenosis	Defined on a per target lesion basis.	12 months
Rate of procedural success	Defined on a per target lesion basis.	Immediately post-procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.

Publications and helpful links

General Publications

• Sun L, Li JJ, Xu YK, Xie YM, Wang SS, Zhang ZW. Initial status and 3-month results relating to the use of biodegradable nitride iron stents in children and the evaluation of right ventricular function. Front Cardiovasc Med. 2022 Aug 1;9:914370. doi: 10.3389/fcvm.2022.914370. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2021
• Primary Completion (ANTICIPATED): July 1, 2024
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (ACTUAL): July 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Stenosis, Pulmonary Artery
• Other Study ID Numbers: IBS Angel-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No