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

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 Patient who have already participated in another drug or medical device clinical trial that have not yet completed or withdrawn within 3 months before the screening period of this trial.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.