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
1 other identifier
interventional
82
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2021
CompletedStudy Start
First participant enrolled
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 19, 2021
November 1, 2021
3 years
June 11, 2021
November 18, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (44)
Rate of technical success
Immediately post-procedure
Rate of freedom from in-stent restenosis
1 month
Rate of freedom from in-stent restenosis
3 months
Rate of freedom from in-stent restenosis
6 months
Rate of device-related adverse events
1 month
- +39 more secondary outcomes
Study Arms (1)
IBS Angel
EXPERIMENTALIron Bioresorbable Scaffold System
Interventions
Subjects in this arm will be implanted with IBS Angel.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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, China
Related Publications (1)
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.
PMID: 35979021DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2021
First Posted
July 22, 2021
Study Start
July 13, 2021
Primary Completion
July 1, 2024
Study Completion
December 1, 2025
Last Updated
November 19, 2021
Record last verified: 2021-11