SirolimUs CoaTed Balloon for The TrEatment of Below The Knee Arterial Disease

Inclusion Criteria:

1. Age ≥ 21 years or minimum age
2. Rutherford class 4 to 6 in the target limb Intraoperative Inclusion Criteria
3. Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions)from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is consideredas one lesion if there is maximum of 30mm gap between lesions at discretion ofinvestigator. Below the knee arteries are tibioperoneal trunk, anterior tibial artery,posterior tibial artery and peroneal artery
4. Inflow free from flow limiting lesions (<50% stenosis) confirmed by duplex orangiography. Subjects with flow limiting inflow lesions (>50% stenosis) can beincluded if lesion had been treated successfully (<30% residual stenosis) before orduring the index procedure.
5. Target vessel has angiographically documented run off to the foot after treatment (ie.without significant stenosis)

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 pregnant or planning to become pregnant during the course of the study
4. Heel gangrene
5. Prior bypass surgery of target vessel
6. Planned amputation of the target limb
7. Previously implanted stent in the target lesion
8. Vulnerable or protected adults
9. Bleeding diathesis or another disorder such as gastrointestinal ulceration whichrestrict the use of clopidogrel or aspirin
10. Known allergy to sirolimus Intraoperative Exclusion Criteria
11. Failure to successfully cross the target lesion with a guide wire (successful crossingmeans tip of the guide wire distal to the target lesion in the absence of flowlimiting dissections or perforations).
12. Target vessel has lesions extending beyond the ankle joint
13. Failure to obtain <30% residual stenosis in a pre-existing lesion
14. Lesions requiring retrograde access (SAFARI)
15. Highly calcified lesions (Contiguous calcification on both sides of the lesion)
16. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during theindex procedure. (Non-compliant balloons are not considered specialty balloons)