search
Back to results

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

Primary Purpose

Pulmonary Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iron Bioresorbable Scaffold System (IBS Angel)
Sponsored by
Biotyx Medical (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Artery Stenosis

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept 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.
  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.

Sites / Locations

  • The Second Xiangya Hospital of Central South University
  • Children's Hospital of Chongqing Medical University
  • The People's Hospital of GaozhouRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Fuwai Yunnan Cardiovascular Hospital
  • Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • General Hospital of Northern Theater Command of Chinese People's Liberation Army
  • Shenzhen Children's Hospital
  • Fuwai Central China Cardiovascular Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IBS Angel

Arm Description

Iron Bioresorbable Scaffold System

Outcomes

Primary Outcome Measures

Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Rate of procedural success
Defined on a per target lesion basis.

Secondary Outcome Measures

Rate of technical success
Defined on a per target lesion basis.
Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Rate of device-related adverse events
Rate of device-related serious adverse events
Rate of device-related adverse events
Rate of device-related serious adverse events
Rate of device-related adverse events
Rate of device-related serious adverse events
Rate of device-related adverse events
Rate of device-related serious adverse events
Rate of device-related adverse events
Rate of device-related serious adverse events
Rate of unplanned surgery or re-intervention
Rate of unplanned surgery or re-intervention
Rate of unplanned surgery or re-intervention
Rate of unplanned surgery or re-intervention
Rate of unplanned surgery or re-intervention
Rate of stent thrombosis
Rate of stent thrombosis
Rate of stent thrombosis
Rate of stent thrombosis
Rate of stent thrombosis
Rate of all-cause death
Rate of all-cause death
Rate of all-cause death
Rate of all-cause death
Rate of all-cause death
Rate of stent displacement
Rate of stent displacement
Rate of stent displacement
Rate of stent displacement
Rate of adverse events
Rate of serious adverse events
Rate of adverse events
Rate of serious adverse events
Rate of adverse events
Rate of serious adverse events
Rate of adverse events
Rate of serious adverse events
Rate of adverse events
Rate of serious adverse events
Rate of device deficiency

Full Information

First Posted
June 11, 2021
Last Updated
November 18, 2021
Sponsor
Biotyx Medical (Shenzhen) Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04973540
Brief Title
A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotyx Medical (Shenzhen) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Artery Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBS Angel
Arm Type
Experimental
Arm Description
Iron Bioresorbable Scaffold System
Intervention Type
Device
Intervention Name(s)
Iron Bioresorbable Scaffold System (IBS Angel)
Intervention Description
Subjects in this arm will be implanted with IBS Angel.
Primary Outcome Measure Information:
Title
Rate of freedom from in-stent restenosis
Description
Defined on a per target lesion basis.
Time Frame
12 months
Title
Rate of procedural success
Description
Defined on a per target lesion basis.
Time Frame
Immediately post-procedure
Secondary Outcome Measure Information:
Title
Rate of technical success
Description
Defined on a per target lesion basis.
Time Frame
Immediately post-procedure
Title
Rate of freedom from in-stent restenosis
Description
Defined on a per target lesion basis.
Time Frame
1 month
Title
Rate of freedom from in-stent restenosis
Description
Defined on a per target lesion basis.
Time Frame
3 months
Title
Rate of freedom from in-stent restenosis
Description
Defined on a per target lesion basis.
Time Frame
6 months
Title
Rate of device-related adverse events
Time Frame
1 month
Title
Rate of device-related serious adverse events
Time Frame
1 month
Title
Rate of device-related adverse events
Time Frame
3 months
Title
Rate of device-related serious adverse events
Time Frame
3 months
Title
Rate of device-related adverse events
Time Frame
6 months
Title
Rate of device-related serious adverse events
Time Frame
6 months
Title
Rate of device-related adverse events
Time Frame
12 months
Title
Rate of device-related serious adverse events
Time Frame
12 months
Title
Rate of device-related adverse events
Time Frame
24 months
Title
Rate of device-related serious adverse events
Time Frame
24 months
Title
Rate of unplanned surgery or re-intervention
Time Frame
1 month
Title
Rate of unplanned surgery or re-intervention
Time Frame
3 months
Title
Rate of unplanned surgery or re-intervention
Time Frame
6 months
Title
Rate of unplanned surgery or re-intervention
Time Frame
12 months
Title
Rate of unplanned surgery or re-intervention
Time Frame
24 months
Title
Rate of stent thrombosis
Time Frame
1 month
Title
Rate of stent thrombosis
Time Frame
3 months
Title
Rate of stent thrombosis
Time Frame
6 months
Title
Rate of stent thrombosis
Time Frame
12 months
Title
Rate of stent thrombosis
Time Frame
24 months
Title
Rate of all-cause death
Time Frame
1 month
Title
Rate of all-cause death
Time Frame
3 months
Title
Rate of all-cause death
Time Frame
6 months
Title
Rate of all-cause death
Time Frame
12 months
Title
Rate of all-cause death
Time Frame
24 months
Title
Rate of stent displacement
Time Frame
1 month
Title
Rate of stent displacement
Time Frame
3 months
Title
Rate of stent displacement
Time Frame
6 months
Title
Rate of stent displacement
Time Frame
12 months
Title
Rate of adverse events
Time Frame
1 month
Title
Rate of serious adverse events
Time Frame
1 month
Title
Rate of adverse events
Time Frame
3 months
Title
Rate of serious adverse events
Time Frame
3 months
Title
Rate of adverse events
Time Frame
6 months
Title
Rate of serious adverse events
Time Frame
6 months
Title
Rate of adverse events
Time Frame
12 months
Title
Rate of serious adverse events
Time Frame
12 months
Title
Rate of adverse events
Time Frame
24 months
Title
Rate of serious adverse events
Time Frame
24 months
Title
Rate of device deficiency
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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. 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. Patients who are not suitable for participating the trial as per investigator judgement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Xia
Phone
86 13760184511
Email
xiaying@lifetechmed.com
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenfei Fang
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qijian Yi
Facility Name
The People's Hospital of Gaozhou
City
Gaozhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lian Hu
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiwei Zhang
Facility Name
Fuwai Yunnan Cardiovascular Hospital
City
Kunming
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gejun Zhang
Facility Name
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fen Li
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Chen
Facility Name
General Hospital of Northern Theater Command of Chinese People's Liberation Army
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiguang Wang
Facility Name
Shenzhen Children's Hospital
City
Shenzhen
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boning Li
Facility Name
Fuwai Central China Cardiovascular Hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taibing Fan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35979021
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs