This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLRâ„¢ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
Who can participate
Age range18 Years
SexALL
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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 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.
✓. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.
✓. 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.
✓. 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.
✓. Target lesions must have a diameter stenosis of ≥ 70% (including total occlusions) by visual estimate and must be indicated for PTA treatment.
Exclusion criteria
✕. 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:
. 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.
✕. Subject has acute limb ischemia with onset of index limb symptoms less than 2 weeks prior to index procedure.
✕. Subjects has wounds that are deemed to be neuropathic or non-ischemic in nature or any venous or mixed wounds.
✕. Subject has had prior major amputation of the ipsilateral extremity or planned major amputation of either leg.