AzTrials
AzTrials

Pulmonary Artery StenosisIRISNCT04973540

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

A study testing Iron Bioresorbable Scaffold System (IBS Angel) in people with Pulmonary Artery Stenosis, run by Biotyx Medical (Shenzhen) Co., Ltd. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 1 year to 14 years
Conditions the study is for
Pulmonary Artery Stenosis
What is being tested?
Iron Bioresorbable Scaffold System (IBS Angel)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
10 sitesChina
Study dates
13 Jul 2021to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

Ying Xia contact

86 13760184511

xiaying@lifetechmed.com

10 sites in 1 country

China10 sites, 10 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha

    Zhenfei Fang

    Not yet recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing

    Qijian Yi

    Not yet recruiting

  • The People's Hospital of Gaozhou

    Gaozhou

    Lian Hu

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Zhiwei Zhang

    Recruiting

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming

    Gejun Zhang

    Not yet recruiting

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

    Shanghai

    Fen Li

    Not yet recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

    Sun Chen

    Not yet recruiting

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

    Shenyang

    Qiguang Wang

    Not yet recruiting

  • Shenzhen Children's Hospital

    Shenzhen

    Boning Li

    Not yet recruiting

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou

    Taibing Fan

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Iron Bioresorbable Scaffold System (IBS Angel)
Medical subject headings
Stenosis, Pulmonary Artery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iron Bioresorbable Scaffold System (IBS Angel)Device

    Subjects in this arm will be implanted with IBS Angel.

Study groups in NCT04973540
Study groupRoleWhat they receive
IBS AngelExperimentalIron Bioresorbable Scaffold System
Receives: Device: Iron Bioresorbable Scaffold System (IBS Angel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of freedom from in-stent restenosis

    Defined on a per target lesion basis.

    Measured: 12 months

  2. Rate of procedural success

    Defined on a per target lesion basis.

    Measured: Immediately post-procedure

Secondary outcomes (44)

  1. Rate of technical success

    Defined on a per target lesion basis.

    Measured: Immediately post-procedure

  2. Rate of freedom from in-stent restenosis

    Defined on a per target lesion basis.

    Measured: 1 month

  3. Rate of freedom from in-stent restenosis

    Defined on a per target lesion basis.

    Measured: 3 months

  4. Rate of freedom from in-stent restenosis

    Defined on a per target lesion basis.

    Measured: 6 months

  5. Rate of device-related adverse events

    Measured: 1 month

  6. Rate of device-related serious adverse events

    Measured: 1 month

  7. Rate of device-related adverse events

    Measured: 3 months

  8. Rate of device-related serious adverse events

    Measured: 3 months

  9. Rate of device-related adverse events

    Measured: 6 months

  10. Rate of device-related serious adverse events

    Measured: 6 months

  11. Rate of device-related adverse events

    Measured: 12 months

  12. Rate of device-related serious adverse events

    Measured: 12 months

  13. Rate of device-related adverse events

    Measured: 24 months

  14. Rate of device-related serious adverse events

    Measured: 24 months

  15. Rate of unplanned surgery or re-intervention

    Measured: 1 month

  16. Rate of unplanned surgery or re-intervention

    Measured: 3 months

  17. Rate of unplanned surgery or re-intervention

    Measured: 6 months

  18. Rate of unplanned surgery or re-intervention

    Measured: 12 months

  19. Rate of unplanned surgery or re-intervention

    Measured: 24 months

  20. Rate of stent thrombosis

    Measured: 1 month

  21. Rate of stent thrombosis

    Measured: 3 months

  22. Rate of stent thrombosis

    Measured: 6 months

  23. Rate of stent thrombosis

    Measured: 12 months

  24. Rate of stent thrombosis

    Measured: 24 months

  25. Rate of all-cause death

    Measured: 1 month

  26. Rate of all-cause death

    Measured: 3 months

  27. Rate of all-cause death

    Measured: 6 months

  28. Rate of all-cause death

    Measured: 12 months

  29. Rate of all-cause death

    Measured: 24 months

  30. Rate of stent displacement

    Measured: 1 month

  31. Rate of stent displacement

    Measured: 3 months

  32. Rate of stent displacement

    Measured: 6 months

  33. Rate of stent displacement

    Measured: 12 months

  34. Rate of adverse events

    Measured: 1 month

  35. Rate of serious adverse events

    Measured: 1 month

  36. Rate of adverse events

    Measured: 3 months

  37. Rate of serious adverse events

    Measured: 3 months

  38. Rate of adverse events

    Measured: 6 months

  39. Rate of serious adverse events

    Measured: 6 months

  40. Rate of adverse events

    Measured: 12 months

  41. Rate of serious adverse events

    Measured: 12 months

  42. Rate of adverse events

    Measured: 24 months

  43. Rate of serious adverse events

    Measured: 24 months

  44. Rate of device deficiency

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start13 Jul 2021
  3. Primary completionJul 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973540
Sponsor's protocol ID
IBS Angel-01
Acronym
IRIS
Status last verified
Nov 2021
First submitted
11 Jun 2021
Last updated
19 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35979021

Questions about this trial

What is this clinical trial studying?

A study testing Iron Bioresorbable Scaffold System (IBS Angel) in people with Pulmonary Artery Stenosis, run by Biotyx Medical (Shenzhen) Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Xia (86 13760184511, xiaying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of freedom from in-stent restenosis (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in