SELUTION4BTK Trial

Clinical Inclusion Criteria: 1. Subject age is ≥ 18 years or older depending on local regulations. 2. Subject life expectancy is ≥ 1 year. 3. Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of \> 2 weeks duration. 4. Subject is willing and able to provide written informed consent and comply with study procedures and required follow-up evaluations. 5. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure. Angiographic Inclusion Criteria: Subjects must meet all the following criteria to be enrolled in the trial: 1. Target lesion(s) must be de novo or non-stented restenotic lesion(s) located within the BTK arteries distal to the tibial plateau and above the tibiotalar joint line. BTK arteries include the P3 segment of the popliteal artery, the tibio-peroneal trunk, peroneal artery, anterior tibial artery, and posterior tibial artery. 2. BTK Target lesions cannot be contiguous with inflow lesions and at least 3 cm of normal artery should extend beyond the tibial plateau to ensure there is no overlap. 3. Target lesions must have a diameter stenosis of ≥ 70% (including total occlusions) by visual estimate and must be indicated for PTA treatment. 4. Target vessel reference diameter(s) are ≥ 2mm and ≤ 4mm. Note: the SELUTION SLR 014 DEB and the control PTA balloon size cannot exceed 4.0 mm. 5. Target lesions must be confined to a single target vessel. NOTE: Subjects with other non-target BTK lesions in separate non-target vessels may be enrolled, provided that the non-target lesions have been successfully treated (residual stenosis ≤ 30% with no distal embolization or flow limiting ≥ Grade C dissection). NOTE: Any adjunctive therapies are permitted for the treatment of non-target BTK lesions, but no DEB or DES may be used. 6. Any target lesion must be ≥ 30 mm in length and the total combined length of all target lesions must be ≤ 140 mm (total treatment length ≤ 150 mm allowing for 5 mm proximal and distal shoulder treatment). Note: All target lesions and all inflow lesions must be treatable by one or more SELUTION SLR 014/018 DEB(s) such that the total planned per-subject drug dose (calculated by summing the drug dose of all individual planned balloon sizes) would be ≤ 7069 μg. Note: A total treated segment length of ≤ 150 mm for BTK and ≤ 200 mm for inflow segment is acceptable irrespective of DEB balloon diameter. 7. The tibial and pedal runoff distal to the target lesions must be patent OR the target vessel(s) must reconstitute above the ankle or display normal terminal branching as follows: 1. If the target vessel is the P3 segment, any 1 of the 3 distal arteries must show a patent (≤ 50% stenosis by visual estimate) outflow. 2. If the target vessel is the peroneal artery, the artery must demonstrate normal terminal branching. 3. If the target vessel is the anterior tibial (AT) or posterior tibial (PT) artery, the artery must reconstitute ≥ 1 cm above the tibiotalar joint to provide an intact runoff vessel (AT: dorsalis pedis; PT: plantar artery). 4. If the target vessel is the tibio-peroneal trunk, outflow for either the peroneal OR the posterior tibial artery must be patent (≤ 50% stenosis by visual estimate). 8. Subjects is free of significant inflow vessel disease or any inflow disease has been successfully treated (see angiographic inclusion # 9). Significant inflow disease is defined as ≥ 50% stenosis by visual estimate. Inflow vessels include the ipsilateral common iliac, external iliac, common femoral, profunda femoris, superficial femoral or popliteal artery proximal (≥ 3 cm) to the tibial plateau. Note: If access site doesn't permit angiographic imaging of the common iliac and common femoral artery (CFA), then non-invasive imaging (CTA or MRA) must be provided to exclude presence of significant inflow disease. If non-invasive imaging is not possible, a DUS of the CFA with a multiphasic wave form excluding significant disease AND a palpable ipsilateral femoral pulse must be documented. 9. Subjects with significant inflow disease (≥ 50% stenosis by visual estimate) must have documented successful treatment before randomizing the subject. Successful treatment of inflow disease is defined as ≤ 30% final residual stenosis and no distal embolization or flow-limiting \> Grade C dissection. Note: Treatment of the common femoral and profunda femoris is not permitted. Inflow vessel treatment can be performed with any commercially available non-DCB or non-DES device; if DCB treatment is required, SELUTION SLR 018 must be used. 10. The BTK target lesion preparation must be documented to be successful by angiography (≤ 30% residual stenosis and no distal embolization or flow-limiting ≥ Grade C dissection) before randomization. Note: Lesion preparation can include atherectomy (rotational, orbital, directional or laser), cutting, scoring, contoured balloons or intravascular lithotripsy and PTA only. Clinical Exclusion Criteria: Subjects will be excluded if any of the following criteria apply: 1. Subject has extensive tissue loss (Rutherford category 6) extending above the trans metatarsal level, salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations. This includes subjects with: 1. Osteomyelitis involving proximal to the metatarsal head(s) 2. Any heel wound or wound with calcaneal bone involvement d) Wounds that would require flap coverage or complex wound management for large soft tissue defect e) Full-thickness wounds on the dorsum of the foot with exposed tendon or bone 2. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or has undergone renal transplantation. 3. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within