SELUTION4BTK Trial

Eligibility Criteria

• 1. Subject age is ≥ 18 years or older depending on local regulations.
• 2. Subject life expectancy is ≥ 1 year.
• 3. Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of \> 2 weeks duration.
• 4. Subject is willing and able to provide written informed consent and comply with study procedures and required follow-up evaluations.
• 5. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.
• 1. Subject has extensive tissue loss (Rutherford category 6) extending above the trans metatarsal level, salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations. This includes subjects with:
• 1. Osteomyelitis involving proximal to the metatarsal head(s)
• 2. Any heel wound or wound with calcaneal bone involvement
• 2. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or has undergone renal transplantation.
• 3. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
• 4. Subject has acute limb ischemia with onset of index limb symptoms less than 2 weeks prior to index procedure.
• 5. Subjects has wounds that are deemed to be neuropathic or non-ischemic in nature or any venous or mixed wounds.
• 6. Subject has had prior major amputation of the ipsilateral extremity or planned major amputation of either leg.
• 7. Target limb iliac or common femoral artery bypass within 6 weeks of index procedure.
• 8. Prior (within 14 days) or planned (within 30 days) surgical or endovascular procedures. The following procedures are permitted:
• 1. Target limb inflow treatment at the index procedure, provided it meets the criteria in Angiographic Inclusion Criteria #12
• 2. Contralateral limb iliac artery treatment
• 3. Diagnostic angiography
• 4. Foot wound debridement
• 5. Planned minor amputation of digit(s) at the phalangeal level
• 9. Target lesion has undergone prior DCB within 1 year, or ANY prior DES or bare metal stent (BMS) treatment (no in-stent restenosis \[ISR\] treatment is permitted). Note: Prior stent is permitted if the target lesion is located ≥ 30 mm from the stent AND there is ≤ 30% in-stent diameter stenosis.
• 10. Target lesion(s) requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, stenting, cryoplasty, brachytherapy, or re-entry device. Note: The following adjunctive lesion preparation therapies are permitted: Atherectomy (rotational, orbital, directional or laser), cutting/scoring/contoured balloon, or intravascular lithotripsy.
• 11. Target lesion requires treatment via pedal access or upper extremity access.
• 12. Subject has undergone non-coronary artery treatment with any limus-based drug coated balloon (DCB) or DES or other device within 3 months prior to index procedure.
• 13. Subject has known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure (such as contrast agent, heparin, bivalirudin) that cannot be adequately pre-treated.
• 14. Subject has contraindication to antiplatelet therapy.
• 15. Subject has experienced disabling stroke or ST-segment elevation myocardial infarction (STEMI) within 3 months of index procedure.
• 16. Subject has acute coronary syndrome. Stabilized Acute Coronary Syndrome (ACS) is permitted.
• 17. Subject has non-atherosclerotic disease of the target vessel (including aneurysmal disease and vasculitis) or Buerger's disease.
• 18. Subject has hypercoagulable state or disorder, or coagulopathy, including platelet count ≤ 100,000 per microliter.
• 19. Subject has systemic infection (White Blood Count \[WBC\] \> 12,000 and febrile). \[Note: Enrollment permitted after successful treatment of infection with resolution of leukocytosis and/or febrile state\].
• 20. Subject is known to be immune compromised (e.g., Human Immunodeficiency virus \[HIV\], Systemic Lupus Erythematosus \[SLE\]) or is receiving treatment with immune suppressive medications (NOTE: topical corticosteroids are permitted)
• 21. Subject is receiving (or is scheduled to receive) cancer treatment with surgery or chemotherapy or radiation therapy or has metastatic malignancy. Note: local application of chemotherapeutic creams is allowed.
• 22. Subject has New York Heart Association (NYHA) class IV congestive heart failure.
• 23. Subject is bedridden.
• 24. Subject has a body mass index (BMI) \< 18.
• 25. Subject is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
• 26. Subject has other anatomic, medical, social, or psychological conditions that in the investigator's opinion could limit the patient's ability to participate in the clinical study and/or comply with the follow-up requirements.