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

Inclusion criteria

• Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \> 21 years OR adulthood minimum age (depending on the US state regulations)
• Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
• Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative Inclusion Criteria:
• 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 considered as one lesion if there is maximum of 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. Inflow free from flow limiting lesions (\<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\>50% stenosis) can be included if lesion had been treated successfully (\<30% residual stenosis) before or during the index procedure.
• Target vessel has angiographically documented unimpaired (\<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/ Posterior Tibial Artery)

Exclusion criteria

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