The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

Inclusion Criteria

• Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
• Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
• Subject has chronic, symptomatic lower limb ischemia, determined by Rutherford categories 4 or 5 in the target limb, with wound(s) confined to toes/forefoot
• Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator

Intra-procedure Inclusion Criteria:

• Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
• Target lesion(s) must be at least 4cm above the ankle joint
• A single target lesion per vessel, in up to 2 vessels, in a single limb
• Degree of stenosis ≥ 70% by visual angiographic assessment
• Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT
• Total target lesion length (or series of lesion segments) to be treated is ≤ 70 mm for phase A RCT prior to the data monitoring committee's approval for stent overlap. (Note: Lesion segment(s) must be fully covered with one DES BTK stent, if randomized to stent)
• Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm for phase A RCT after the data monitoring committee's approval for stent overlap (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents, if randomized to stent)
• Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
• Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
• Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
• Guidewire has successfully crossed the target lesion(s)

Exclusion Criteria

• Life expectancy ≤ 1year
• Stroke ≤ 90 days prior to the procedure date
• Prior or planned major amputation in the target limb
• Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
• Previously implanted stent in the target vessel(s)
• Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
• Renal failure as measured by a GFR ≤ 30ml/min per 1.73m2, measured ≤ 30 days prior to the procedure date
• Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
• NYHA class IV heart failure
• Subject has symptomatic coronary artery disease (ie, unstable angina)
• History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
• Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
• Subject is currently taking Canagliflozin
• Body Mass Index (BMI) 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)
• Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
• Aneurysm is present in the target vessel(s)
• Extremely calcified lesions