Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE

Exclusion Criteria

• •1. Patient is permanently wheel-chair bound or bedridden
• •2. Presence of a stent in the target lesion(s) that was placed during a previous procedure
• •3. The intervention is being performed in preparation for a planned amputation.
• •4. Untreated flow-limiting inflow lesions
• •5. Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
• •6. Previous bypass surgery in the same limb
• •7. Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
• •8. Patients with a history of major disabling stroke within 3 months prior index procedure.
• •9. Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure.
• •10. Untreatable lesion located at the distal outflow arteries
• •11. Patients with uncorrected bleeding disorders
• •12. Aneurysm located at the level of the SFA/popliteal artery
• •13. Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• •14. Any condition which prevents patient from complying with the study protocol or if patient has a life expectancy of \<1yr.
• •15. Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• •16. Patients with a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 30 ml/min) and is not dialysis dependent.
• •17. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb)
• •18. Episode of acute limb ischaemia within the previous 1 month
• •19. Use of thrombectomy, cutting balloon, lithotripsy, atherectomy or laser devices during procedure
• •20. Any patient considered to be hemodynamically unstable at onset of procedure
• •21. Patients with a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or other anticoagulant/anti-platelet therapies or sensitivity to contrast media that cannot be adequately premedicated.
• •22. The patient is currently breast-feeding, pregnant or intends to become pregnant.
• •23. Subject receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
• •24. Patient is participating in another research study of a device, medication, biologic or other agent within 30 days which could in the opinion of the investigator affect the results of this study
• •25. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device.