Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

Eligibility Criteria

• 1. Subject with Body Mass Index (BMI) \< 18.
• 2. Subject is pregnant or nursing. Subjects who plan pregnancy during the clinical investigation follow-up period may not be enrolled.
• 3. Estimated life expectancy \<1 year, in the opinion of the Investigator at the time of enrollment.
• 4. Subject is permanently bedridden.
• 5. Subject has known hypersensitivity or contraindication to device materials and their degradants (sirolimus, poly (L-lactide), poly (D, L-lactide), lactic acid, or platinum-iridium) or to study medications (including antiplatelet medications) or to contrast media and who cannot be adequately premedicated.
• 6. Subject has planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure.
• 7. Subject has had revascularization procedure within the target vessel in the previous 3 months
• 8. Subject has prior major amputation (above or below the knee or above the ankle) involving the target limb.
• 9. Subject has planned surgical or endovascular procedure within 6 months following the index procedure.
• 10. Subject who has severe ischemia (ABI ≥ 0.39).
• 11. Subject who has neuropathic lesion(s) with no ischemic component (wounds or ulcers occur on pressure zones of the foot with or without Type 2 diabetes , deformed foot/toes, hematoma, edema ).
• 12. Subject has presence of osteomyelitis or any gangrene above the metatarsal-phalangeal joints, extensive tissue loss with exposed tendons or requiring complex or recurrent surgeries, full thickness heel ulcer, or pure neuropathic ulcers.
• 13. Subject with uncontrolled diabetes with HbA1c \> 10%.
• 14. Subject has a prior stroke or myocardial infarction within 3 months of the index procedure.
• 15. Subject has acute renal failure, severe or end-stage chronic kidney disease (eGFR \< 30 mL/min), or requires dialysis.
• 16. Subject has active systemic infection.
• 17. Subject is receiving immunosuppression therapy and/or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
• 18. Subject has active malignancy (receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the index procedure), active blood dyscrasia or coagulation disorder (platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC \< 3,000 cells/mm3, or hemoglobin \< 8.0 g/dl).
• 19. Subject is an incapacitated individual, defined as a person who is mentally ill, mentally handicapped, or an individual without legal authority to control their activities.
• 20. Subject has significant comorbid condition(s), or other medical, social, or psychological conditions (such as history of substance abuse, e.g., alcohol, cocaine, heroin, etc.), that in the Investigator's opinion may limit the subject's ability to participate or comply with study instructions and follow-up. This includes subjects with symptomatic COVID-19 infection in the past 2 months or asymptomatic COVID-19 positive test in the past 1 month.
• 21. Angiographic evidence of thromboembolism or atheroembolism in the target or non-target vessel as confirmed by angiography.
• 22. Non target lesion located in the popliteal P3 (infrageniculate) segment or treated with atherectomy.
• 23. Presence of aneurysm or acute thrombus in the aorta or lower extremity arteries.
• 24. Prior below-the-knee bypass in the target limb.
• 25. Previously stented lesion(s) or the presence of stents in the target vessel.
• 26. Target vessel(s) have distal hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) outside of the allowed treatment zone (presence of non-target lesions in the target vessel is an exclusion criterion).
• 27. Lesions (target or non-target) with severe calcification (per PACSS 4 classification).
• 28. Unsuccessful treatment of stenosis (≥ 50% stenosis) of in-flow arteries including the P3 segment of the popliteal artery (infrageniculate).
• 29. Absence of a patent pedal artery. Absence of contiguous dorsalis pedis or common plantar arteries if the target vessels are anterior or posterior tibial arteries, respectively.
• 30. Target lesion location requires bifurcation treatment with scaffolding of both branches (kissing scaffold is not allowed). In case of presence of disease at a bifurcation, one vessel can be treated as target and the other as non-target.
• 31. Lesions (target or non-target) in which successful predilatation cannot be achieved.
• 32. Planned atherectomy treatment of any target or non-target lesion.