Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in the Treatment of Below the Knee Arterial Disease

Inclusion Criteria:

1. Age > 21 years or minimum age (is allowed the inclusion of subjects > 21 years ORadulthood minimum age (depending on the US state regulations)

2. Rutherford class 4 with documented WIFI score, not exceeding more than 30% of targetpatient population.

3. Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative Inclusion Criteria:

4. Single or sequential de novo or re-stenotic lesions (stenosis of > 50% orocclusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesionis considered as one lesion if there is maximum of 30 mm gap between lesions atdiscretion of investigator. Below the knee arteries are Tibio-peroneal trunk,Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peronealartery. With documented Distal Run off a maximum of two tibial vessels can betreated in the index procedure. Inflow free from flow limiting lesions (<50%stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflowlesions (>50% stenosis) can be included if lesion had been treated successfully (<30% residual stenosis) before or during the index procedure.

5. Target vessel has angiographically documented unimpaired (<50% stenosis) run offinto a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/Posterior Tibial Artery)

Exclusion Criteria:

1. Comorbid conditions limiting life expectancy ≤ 1 year

2. Subject is currently participating in another investigational drug or device studythat has not reached first primary endpoint yet

3. Subject is lactating, pregnant or planning to become pregnant during the course ofthe study

4. Subject with extensive tissue loss salvageable only with complex foot reconstructionor non-traditional trans metatarsal amputation. This includes subjects with:

5. Osteomyelitis including and/or proximal to the metatarsal head

6. Gangrene involving the plantar skin of the forefoot, midfoot,or heel

7. Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of theforefoot, midfoot, or heel

8. Full thickness heel ulcer with/without calcaneal involvement

9. Any wound with calcaneal bone involvement

10. Wounds that are deemed to be neuropathic or non-ischemic in nature

11. Wounds that would require flap coverage or complex wound management for largesoft tissue defect

12. Full thickness wounds on the dorsum of the foot with exposed tendon or bone

13. Prior bypass surgery of target vessel

14. Planned amputation of the target limb (major)

15. Previously implanted stent in the target lesion

16. Vulnerable or protected adults

17. Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) whichwould prevent the use of mandated antiplatelet agents

18. Known allergy to sirolimus

19. Patients with severe (Stage 4) renal disease, defined eGFR < 30%. Intraoperative exclusion criteria:

20. Failure to successfully cross the target lesion with a guide wire

21. Target vessel has lesions extending beyond the ankle joint

22. Failure to obtain <30% residual stenosis prior to randomization

23. Lesions requiring retrograde access . Retrograde wire crossing is allowed buttreatment must be performed from the antegrade approach.

24. Use of DCBs, bare metal stents, drug eluting stents, specialty balloons oratherectomy devices at the target lesions. (Non-compliant balloons are notconsidered specialty balloons)

25. For Inflow lesions and non-target lesions all the approved devices are allowed.