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

Inclusion Criteria:

1. Patients must between 1 and 14 years old.
2. Patients who have congenital or secondary pulmonary artery stenosis (includingpulmonary artery trunk, left pulmonary artery and right pulmonary artery), and meetingone of the following criteria: A: The pressure gradient across the stenosis ≥20mmHg measured by catheter; B: Thedegree of pulmonary artery stenosis ≥50% ( calculated by (diameter of adjacent normalsegments - residual lumen diameter of the stenosis segment)/diameter of adjacentnormal segments ×100%); C: The ratio of right ventricular systolic pressure to aorticsystolic pressure ≥50%.
3. Patients and whose family have high compliance, voluntarily participate in and signthe 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, suchas hereditary hemochromatosis, etc.
2. Patients with cardiopulmonary function that cannot tolerate surgery, such as severeheart failure (NYHA Grade III and above) that cannot be controlled by active medicaltreatment.
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 orproximal location.
7. Patients with known severe renal or hepatic insufficiency which are unsuitable forindex 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, oranatomical 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 Patient who have already participated in another drug or medical device clinical trialthat have not yet completed or withdrawn within 3 months before the screening periodof this trial.
12. Patients who are not suitable for participating the trial as per investigatorjudgement.