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

Exclusion Criteria

• •1. Comorbid conditions limiting life expectancy ≤ 1 year
• •2. Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
• •3. Subject is lactating, pregnant or planning to become pregnant during the course of the study
• •4. Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with:
• •1. Osteomyelitis including and/or proximal to the metatarsal head
• •2. Gangrene involving the plantar skin of the forefoot, midfoot,or heel
• •3. Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
• •4. Full thickness heel ulcer with/without calcaneal involvement
• •5. Any wound with calcaneal bone involvement
• •6. Wounds that are deemed to be neuropathic or non-ischemic in nature
• •7. Wounds that would require flap coverage or complex wound management for large soft tissue defect
• •8. Full thickness wounds on the dorsum of the foot with exposed tendon or bone
• •5. Prior bypass surgery of target vessel
• •6. Planned amputation of the target limb (major)
• •7. Previously implanted stent in the target lesion
• •8. Vulnerable or protected adults
• •9. Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents
• •10. Known allergy to sirolimus
• •11. Subjects with severe (Stage 4) renal disease, defined eGFR \< 30.
• •12. Failure to successfully cross the target lesion with a guide wire
• •13. Target vessel has lesions extending beyond the ankle joint
• •14. Failure to obtain \<30% residual stenosis prior to randomization
• •15. Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.
• •16. Use of commercially available DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons). For Inflow and non-target lesions all the approved devices are allowed.