Clinical trial NCT04973540: A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
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
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Artery Stenosis
Lead sponsor: Biotyx Medical (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of freedom from in-stent restenosis
timeFrame: 12 months
measure: Rate of procedural success
timeFrame: Immediately post-procedure
Secondary outcomes:
measure: Rate of technical success
timeFrame: Immediately post-procedure
measure: Rate of freedom from in-stent restenosis
timeFrame: 1 month
measure: Rate of freedom from in-stent restenosis
timeFrame: 3 months
measure: Rate of freedom from in-stent restenosis
timeFrame: 6 months
measure: Rate of device-related adverse events
timeFrame: 1 month
measure: Rate of device-related serious adverse events
timeFrame: 1 month
measure: Rate of device-related adverse events
timeFrame: 3 months
measure: Rate of device-related serious adverse events
timeFrame: 3 months
measure: Rate of device-related adverse events
timeFrame: 6 months
measure: Rate of device-related serious adverse events
timeFrame: 6 months
measure: Rate of device-related adverse events
timeFrame: 12 months
measure: Rate of device-related serious adverse events
timeFrame: 12 months
measure: Rate of device-related adverse events
timeFrame: 24 months
measure: Rate of device-related serious adverse events
timeFrame: 24 months
measure: Rate of unplanned surgery or re-intervention
timeFrame: 1 month
measure: Rate of unplanned surgery or re-intervention
timeFrame: 3 months
measure: Rate of unplanned surgery or re-intervention
timeFrame: 6 months
measure: Rate of unplanned surgery or re-intervention
timeFrame: 12 months
measure: Rate of unplanned surgery or re-intervention
timeFrame: 24 months
measure: Rate of stent thrombosis
timeFrame: 1 month
measure: Rate of stent thrombosis
timeFrame: 3 months
measure: Rate of stent thrombosis
timeFrame: 6 months
measure: Rate of stent thrombosis
timeFrame: 12 months
measure: Rate of stent thrombosis
timeFrame: 24 months
measure: Rate of all-cause death
timeFrame: 1 month
measure: Rate of all-cause death
timeFrame: 3 months
measure: Rate of all-cause death
timeFrame: 6 months
measure: Rate of all-cause death
timeFrame: 12 months
measure: Rate of all-cause death
timeFrame: 24 months
measure: Rate of stent displacement
timeFrame: 1 month
measure: Rate of stent displacement
timeFrame: 3 months
measure: Rate of stent displacement
timeFrame: 6 months
measure: Rate of stent displacement
timeFrame: 12 months
measure: Rate of adverse events
timeFrame: 1 month
measure: Rate of serious adverse events
timeFrame: 1 month
measure: Rate of adverse events
timeFrame: 3 months
measure: Rate of serious adverse events
timeFrame: 3 months
measure: Rate of adverse events
timeFrame: 6 months
measure: Rate of serious adverse events
timeFrame: 6 months
measure: Rate of adverse events
timeFrame: 12 months
measure: Rate of serious adverse events
timeFrame: 12 months
measure: Rate of adverse events
timeFrame: 24 months
measure: Rate of serious adverse events
timeFrame: 24 months
measure: Rate of device deficiency
timeFrame: Day 0
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
city: Gaozhou
country: China
facility: The People's Hospital of Gaozhou
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
city: Shanghai
country: China
facility: Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command of Chinese People's Liberation Army
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
Study officials:
References:
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.