SELUTION SLR™ 014 BTK: a Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)

INTERVENTION: Group 1: Device: SELUTION SLR™ DEB 014 a non‐surgical procedure that uses a catheter to inflate a drug‐eluting balloon to open up peripheral below‐the‐knee arteries that have been narrowed by chronic limb‐threatening ischemia Group 2: Device: Plain (Uncoated) Balloon Angioplasty (PTA) a non‐surgical procedure that uses a catheter to inflate a commercially available, non‐drug‐eluting balloon to open up peripheral below‐the‐knee arteries that have been narrowed by chronic limb‐threatening ischemia CONDITION: Atherosclerosis of the Extremity Arteries: Pelvic leg type, with pain at rest, Atherosclerosis of the extremity arteries: Pelvic leg type, with ulceration, Atherosclerosis of the extremity arteries: Pelvic leg type, with gangrene PRIMARY OUTCOME: 1. Freedom from target lesion occlusion, above‐ankle amputation, or clinically driven target lesion re‐intervention (CD‐TLR) [ Time Frame: 6 months ]. Method: Angiography, if angiography is not available, Duplex Ultrasound (DUS); 2. Freedom from Major Adverse Limb Event (MALE) and all‐cause perioperative death (POD) [ Time Frame: 30 days ] . Method: Angiography SECONDARY OUTCOME: o Device success: ; Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure. [At end of procedure] ; o Procedural (Technical) success ; Device success and residual stenosis =30% on completion angiography by core lab assessment. Denotes successful establishment of at least one BTK flow pathway. [At end of procedure] ; o Clinical success ; Procedural success without procedural complications (death, above‐ankle target limb amputation, thrombosis of the target lesion or TLR) prior to discharge. [At discharge] ; o Primary sustained clinical improvement: ; Freedom from target limb above‐ankle amputation, CD‐TLR and increase in Rutherford category. [At 1, 3, 6, 12, 24, 36 months] ; o Secondary sustained clinical improvement: ; Freedom from target limb amputation and increase in Rutherford class. [At 1, 3, 6, 12, 24, 36 months] ; o Major Adverse Limb Events (MALE) composite endpoint: ; Limb ischemia leading to above‐ankle amputation or major re‐intervention (new bypass graft, jump/ interposition graft revision, thrombectomy/thrombolysis). [At discharge, and 1, 3, 6, 12, 24, 36 months] ; o Major Cardiovascular Events ; MI, Stroke, Cardiovascular death [At discharge, 1, 3, 6, 12, 24, 36 months] ; o Above‐Ankle Amputation: ; Above‐ankle amputation of target limb. [At discharge, and 1, 3, 6, 12, 24, 36] ; o All‐Cause Mortality: ; Death from any cause. [At discharge, and 1, 3, 6, 12, 24, 36, 48, 60 months] ; o Amputation‐Free Survival: ; Freedom from all‐cause mortality and above‐ankle amputation. [At discharge, and 1, 3, 6, 12, 24, 36 months] ; o Duple Xultrasound primary patency: ; Binary primary patency (open/occluded), core lab adjudicated measure. Patency defined as DUS demonstration of prograde flow within all evaluable areas of the treated arterial segment, including 1 cm proximal and distal to the treated arterial segment [At 1, 3, 6, 12, 24 and 36 months] ; o Primary‐assisted patency: ; o Primary assisted patency is defined as freedom from core lab adjudicated occlusion on angiography or, if angiography is not available, on core lab adjudicated duple Xultrasound, irrespective of interventions for stenoses. [At 1, 3, 6, 12, 24, 36 months] ; o Secondary patency: ; o Secondary patency is defined as freedom from permanent occlusion (occlusion at the last follow‐up imaging) as determined by core lab adjudicated angiography or core lab adjudicated duple Xultrasound. [At 1, 3, 6, 12, 24, 36 months] ; o Clinically‐driven TLR: ; Defined as re‐intervention on target lesion(s) due to recurrent/persistent/worsening symptoms and the angiographic finding of =50% restenosis of target lesion. [At 1, 3, 6, 12, 24, 36 months] ; o Clinically‐driven TVR: ; Defined as re‐intervention on target vessel due to recurrent/persistent/worsening symptoms and the angiographic finding of =50% restenosis of target vessel. [At 1, 3, 6, 12, 24, 36 months] ; o Change in Rutherford category from baseline: ; At 1, 3, 6, 12, 24, 36 months ; o Change in ankle brachial inde X(ABI), toe brachial inde X(TBI), and toe pressures from baseline: ; At 1, 3, 6, 12, 24, 36 months ; o WIfI Classification: ; Granular descriptors of Wound, Foot Infection, and Ischemia. At 1, 3, 6, 12, 24, 36 months ; o Change in Quality of Life (QOL) measures from baseline: ; EQ‐5D and VascuQol instruments. At 1, 3, 6, 12, 24 and 36 months ; o Wound Healing: ; o Investigator reported status of each inde Xwound in comparison to baseline. Descriptive categories to be captured on CRFs: 1) Improved 2) Unchanged 3) Worse 4) Healed/Complete Closure [At 1, 3, 6, 12, 24, 36 months] ; o New wounds (appearing at any time after inde Xprocedure) are identified and tracked in similar fashion as inde Xwounds, adopting the initial evaluation & images as “baseline” for future comparisons. ; o Adverse Events: ; Mild‐moderate‐serious, anticipated‐unanticipated, procedure‐related, and device‐related. [At discharge, and 1, 3, 6, 12, 24, 36 months] ; o Inflow Treatment Subgroup (only applicable for patients treated with SELUTION SLR™ 018): ; o Primary patency of the inflow lesion. Primary patency is defined as freedom from inflow lesion revascularization, freedom from restenosis as determined by core lab adjudicated duple Xultrasound peak systolic velocity ratio of =2.4 and absence of occlusion of the inflow lesion, and freedom from core lab adjudicated angiographic stenosis >50%. [At 1, 3, 6, 12, 24, 36 months] ; o Primary‐assisted patency: ; ‐ Primary assisted patency is defined as freedom from restenosis as determined by core lab adjudicated duple Xultrasound peak systolic velocity ratio of =2.4 and absence of occlusion of the inflow lesion, and freedom from core lab adjudicated angiographic stenosis >50%, irrespective of interventions for stenoses. [At 1, 3, 6, 12, 24, 36 months] ; o Secondary patency: ; ‐ Secondary patency is defined as freedom from permanent occlusion (occlusion at the last follow‐up imaging) as determined by core lab adjudicated duple Xultrasound or angiography. [At 1, 3, 6, 12, 24, 36 months] INCLUSION CRITERIA: Clinical INCLUSION CRITERIA: Subject age is = 18 years or older depending on local regulations. Subject life expectancy is = 1 year Subject has documented chronic limb‐threatening ischemia in the target limb with Rutherford classification category 4, 5 or 6 and symptoms of > 2 weeks duration Subject is willing and able to provide written informed consent and comply with study procedures and required follow‐up evaluations Female subjects only: If female, then subjects of childbearing potential must be non‐breastfeeding and have a negative pregnancy test = 7 days before the procedure and be prepared to use effective contraception for 24 months after treatment Angiographic INCLUSION CRITERIA: Target lesion(s) must lie distal to the tibial plateau and above the tibiotalar joint line within the BTK arteries. There is no limitation on total target lesion length. Two in‐line areas of stenosis are considered multiple lesions if a) there is 2 cm o