A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions

Exclusion Criteria

• •1. Patients with previously stented target lesion.
• •2. Patients who have undergone lower extremity arterial intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure.
• •3. Patients with a history of or planned ipsilateral aortoiliac bypass surgery during the index procedure.
• •4. Patients who were expected to undergo amputation of the target limb before the index procedure.
• •5. Patients with an aneurysm, perforation and/or dissection of the target iliac artery before the index procedure.
• •6. Patients who have undergone coronary artery intervention within 30 days before the index procedure, or has such intervention planned for within 30 days after the index procedure (including the index procedure).
• •7. Patients with acute myocardial infarction or angina pectoris within 30 days before the index procedure.
• •8. Patients with a stroke within 3 months before the index procedure, or a stroke more than 3 months before the index procedure accompanied by severe paralysis and aphasia sequelae.
• •9. Patients with known intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
• •10. Patients with known diseases (not related to the trial) that require indefinite or lifelong anticoagulation therapy.
• •11. Patients with known allergies to aspirin, heparin, clopidogrel, contrast agent, poly(lactide), iron and its degradation products.
• •12. Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
• •13. Patients with coagulation insufficiency (platelet count \< 80\*109/L), systemic coagulation disorders or hypercoagulable tendencies.
• •14. Patients with severe hepatic or renal insufficiency (serum creatinine \>2 times the upper limit of normal or on renal dialysis; ALT or AST \> 5 times the upper limit of normal).
• •15. Patients with a life expectancy of less than two years.
• •16. Patient currently participating in another clinical trial, and have not yet completed that trial.
• •17. Patients who are not suitable for participating the trial as per investigator judgement.
• •1. Patients with angiographic evidence of thrombus within or adjacent to the target lesion(s).
• •2. Patients with a history of ipsilateral iliac artery stenting, where the distance between the previously implanted stent and the current target lesion is ≤ 5 mm.
• •3. Patients with coexisting ipsilateral iliac aneurysms or abdominal aortic aneurysms.
• •4. Patients in whom the internal iliac artery is patent, but implanting the stent in the target lesion will block the blood flow from entering the internal iliac artery.
• •5. Patients requiring placement of a study device within 2 cm proximal to the inguinal ligament.
• •6. Patients with severe calcification of the target lesion which makes it impossible for the pre-dilation balloon to reach its nominal diameter.