This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
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 or 5 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.
Osteomyelitis involving proximal to the metatarsal head(s)
Any heel wound or wound with calcaneal bone involvement
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.
Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.