Studie zum Vergleich des neuen medikamentös-beschichteten IN.PACT 014 Ballonkatheters für die Ballonaufdehnung mit einer optimalen herkömmlichen Ballonaufdehnung zur Behandlung von chronischen Totalverschlüssen der Unterschenkelarterien (IN.PACT BTK Studie)

Device: DCB;Device: PTA

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

1. Age =18 years.

2. Subject has been informed of the nature of the study, agrees to participate and has
signed an EC approved consent form.

3. Female subjects of childbearing potential have a negative pregnancy test =7 days
before the procedure and are willing to use a reliable method of birth control for the
duration of study participation.

4. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior
to the study procedure with Rutherford Clinical Category 4 or 5.

5. Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi
classification.

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

7. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.

8. Total occlusions with total lesion length = 40 mm.

9. Lesion must be located in the infrapopliteal arteries and above the ankle joint.

10. Multiple lesions can be treated if located in separate vessels.

11. Presence of documented run-off to the foot.

12. Inflow free from flow-limiting lesion confirmed by angiography.

13. Successful pre-dilatation of the (entire) target lesion.

Exclusion Criteria:

1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the
duration of the study.

2. Planned index limb amputation above the metatarsal level, or any other planned major
surgery within 30 days pre or post-procedure.

3. Lesion and/or occlusions located or extending in the popliteal artery or below the
ankle joint space.

4. Significant inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal
arteries left untreated.

5. Failure to obtain = 30% residual stenosis in pre-existing, hemodynamically significant
inflow lesions in the ipsilateral iliac, SFA and popliteal artery.

6. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed
within target vessels during the index procedure prior to randomization.

7. Previous DCB procedure in the target vessel within 6 months prior to index procedure.

8. Aneurysm in the target vessel.

9. Angiographic evidence of thrombus within target limb.

10. Pre-dilatation resulted in major (= Grade D) flow-limiting dissection or residual
stenosis > 30%.

11. Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation
therapy, stents as part of target vessel treatment.

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

13. Heart failure with Ejection Fraction < 30%.

14. Known or suspected active infection at the time of the index procedure, excluding an
infection of a lower extremity wound on the target limb.

15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi
classification.

16. Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a
risk of major amputation.

17. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond
cortical involvement of the bone per clinical judgement.

18. Impaired renal function (GFR <20 mL/min) and patients on dialysis.

19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on
active treatment.

20. Patient receiving systemic corticosteroid therapy.

21. Known allergies or sensitivities to heparin, aspirin (ASA), other
anticoagulant/anti-platelet therapies which could not be substituted, and/or
paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior
to the index procedure.

22. The patient is currently enrolled in another investigational device or drug trial that
is interfering with the endpoints of this study.

23. Female subjects who are breastfeeding at the time of enrollment.