IRB Study Number 22-1061
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
This is a single-blinded, randomized, controlled superiority clinical trial. Subjects will be randomized 1:1 to one of the two treatment arms: Intervention- treatment with the Selution SLR 014 DEB or Control- treatment with a commercially available PTA (uncoated balloon). This study will demonstrate the SLR 014 DEB compared to the PTA, in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.
Inclusion Criteria
- Subject age is ≥ 18 or older.
- Subject life expectancy is ≥ 1 year.
- Subject has documented CLTI 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 evaluation.
- Female subjects of childbearing potential must be non-breastfeeding and have negative pregnancy test ≤ 7 days before the procedure.
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.
- Subject has chronic renal insufficiency or has undergone renal transplantation.
- Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before the procedure and/or decrease in urine output.
- Subject has 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 ipsilateral extremity or planned major amputation of either leg.
- Target limb iliac or common femoral artery bypass within 6 weeks of index procedure.
- Prior or planned surgical endovascular procedures.
- Subject has body mass index (BMI) < 18
- Subject is bedridden.
- Subject is receiving cancer treatment.
- Subject is immune compromised.
