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.
Parallel
SELUTION SLR™ DEB 014
Devicea 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
Plain (Uncoated) Balloon Angioplasty (PTA)
Devicea 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
Primary Efficacy Endpoint
Hierarchical composite efficacy endpoint determined by pair-wise comparisons among all subjects (Win Ratio method) according to the following pre-specified hierarchy of adverse outcomes: * Major (above-the-ankle) amputation * CD-TLR * Target lesion occlusion by angiography (if angiography is not available, the decision will be made on a secondary modality, in order of preference: computed tomography angiogram \[CTA\], magnetic resonance angiography \[MRA\] or DUS) * Transverse View Area Loss (TVAL%) by angiography.
Primary Safety Endpoint
Freedom from the composite of MALE and all-cause perioperative death (POD). MALE is defined as major (above-the-ankle) amputation or major reintervention (new bypass graft, jump/ interposition graft revision, thrombectomy/thrombolysis) of the index limb.
Primary sustained clinical improvement
A secondary efficacy endpoint defined as freedom from target limb major amputation and CD-TLR AND increase in Rutherford category from baseline.
Secondary sustained clinical improvement
A secondary efficacy endpoint defined as freedom from target limb major amputation AND increase in Rutherford category from baseline.
Major amputation
A secondary efficacy endpoint defined as above-the-ankle amputation of the target limb.
Amputation-free survival
A secondary efficacy endpoint defined as freedom from all-cause mortality and major amputation.
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