AcoArt Litos PCB Below-the-knee Global Trial

Inclusion Criteria:

• General Inclusion Criteria

1. Age ≥ 18 years at the time of consent;

2. Subjects has been informed of the nature of the study, is willing to comply with allrequired follow-up evaluations within the defined follow-up visit windows and hassigned an Institutional Review Board(IRB)/Ethics Commitee(EC) approved consent form;

3. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 daysbefore the procedure and are willing to use a reliable method of birth control forthe duration of study participation. Female subjects will be exempted from thisrequirement in case they are sterile, infertile, or have been post-menopausal for atleast 12 months (no menses);

4. Life expectancy > 1 year in the Investigator's opinion;

5. Subject presenting with documented chronic limb-threatening ischemia(CLTI) in thetarget limb defined as Rutherford category 4 or 5;

6. In case of Rutherford category 5: Subjects with documented wound score 0-1,infection grade 0-2 and ischemia grade 2-3 according to the wound ischemia footinfection (WIfI) classification;

7. No other prior surgical or vascular interventions within 2 weeks before and/orplanned 30 days after the protocol treatment.

• Angiographic Inclusion Criteria

8. Reference Vessel Diameter(RVD) ≥2.0 and ≤ 4.0mm and able to be treated withavailable device size matrix;

9. Total length of target lesion (including significant stenosis 70~99% or occlusion) ≤ 190mm;

10. The lesion must be located in the infrapopliteal arteries and above the ankle joint.Lesions may not extend proximal to the P3 segment of the popliteal artery indicatedby the tibial plateau or below the tibiotalar joint(arteries of the foot). Thetreatment(investigational device or PTA, including pre-dilatation) may not extendbeyond these indicated regions for more than 1cm;

11. Presence of documented run-off to the foot(clearly visible at least one of thefollowing run-off vessels; dorsalis pedis or pedal arch or plantar arteries byangiography). The target vessels should give direct or indirect run-off to the foot;

12. Absence of flow-limiting(≥ 50% stenosis) in-flow lesions confirmed by angiography.Patients with flow-limiting inflow lesions can be included if the lesion(s) havebeen treated successfully before enrollment, with a maximum residual restenosis of ≤30% per visual assessment. If an inflow lesion must be treated within or proximalto the P3 segment of the popliteal artery, there must be a minimum of 3 cm healthyvascular segment between this(treated) lesion and the infrapopliteal target lesion;

13. Successful pre-dilatation of the(entire) target lesion. Success being documented byangiographic visual estimate of ≤ 50% residual diameter stenosis of the targetlesion and no flow limiting dissection(< Grade D dissection). Target lesion is notconsidered non-dilatable by the operator due to concentric, circumferential calciumand target lesion can be treated successfully by balloon angioplasty without theneed for bail-out stenting.

Exclusion Criteria:

• General Exclusion Criteria

1. Planned index limb amputation above the metatarsal level, or any other planned majorsurgery within 30 days pre- or post-procedure. A planed amputation including andbelow the metatarsal level(1 or multiple rays) is accepted.

2. Recent MI or stroke < 30 days prior to the index procedure;

3. Known or suspected active infection at the time of the index procedure(abnormalwhite blood cell count, fever, sepsis, or positive blood culture), with theexception of a localized, controlled infection of a lower extremity wound on thetarget limb(only WIfI infection grade 0-2 allowed);

4. Subjects with infection grade 3 and ischemia grade 0 and 1 according to WIfIclassification;

5. Subjects not independently ambulating.

6. Subjects with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with arisk for major amputation; Subjects with uncomplicated ulcers can be included;

7. Subjects with documented active osteomyelitis, excluding the phalanges, that isbeyond cortical involvement of the bone per clinical judgement;

8. Subjects with vasculitis, systemic Lupus Erythematosus or polymyalgia rheumatica onactive treatment;

9. Subjects with impaired renal function defined as eGFR <30 ml/min or on dialysis;

10. Patient receiving systemic corticosyeroid therapy(expected dosage exceeding 5 mg ofprednisolone or equivalent, per day, during the initial 9 months after procedure);

11. Known allergies or sensitivities to heparin, aspirin(ASA), otheranticoagulant/anti-platelet therapies which could not be substitued, and/orpaclitaxel or an allergy to contrast media that cannot be adequately pre-treatedprior to the index procedure;

12. Subjects currently enrolled in another investigational device, drug, or biologicaltrial;

13. Femal subjects who are breast feeding at the time of enrollment;

14. Significant gastrointestinal bleeding or any coagulopathy that would contraindicatethe use of anti-platelet therapy;

15. Any severe medical comorbidities(e.g., untreated CAD/CHF, NYHA class IV heartfailure, Left Ventricular ejection fraction(LVEF) </= 30%(obtained within 1 month ofindex procedure), severe COPD, metastatic malignacy, etc.) that would precludecompliance with the study protocol or currently receiving immune-suppressive,chemotherapeutic, or radiation therapy;

• Angiographic Exclusion Criteria

16. Occlusions located or extending distal to the ankle joint space;

17. Untreated (≥50% measured by angiography) inflow lesion or occlusion in theipsilateral iliac, SFA nad popliteal arteries;

18. Failure to obtain a ≤30% residual stenosis in pre-existing, hemodynamicallysignificant(≥50% measured by angiography) in flow lesions in the ipsilateral iliac,SFA and popliteal artery. Inflow lesions should be treated per standard of care;

19. Prior stent(s) or bypass surgery within the target vessel(s) (including stentsplaced within target vessels during the index procedure prior to randomization);

20. Previous procedure with drug-coated balloons in the target vessels within 6 monthsprior to index procedure.

21. Aneurysm in the target vessel;

22. Angiographic evidence of thrombus within target limb;

23. Pre-dilatation resulted in a major(≥ Grade D) flow-limiting dissection(observed on 2orthogonal views) or residual stenosis >50%;

24. Use of alternative therapy, e.g. atherectomy, scoring balloon, laser, radiationtherapy, stents as part of target vessel treatment.