Peripheral Artery Disease Clinical Trials

• Subject must be ≥ 18 and ≤ 95 years of age

• Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 \< 30 mm Hg) and

∙ Rutherford Classification 5, ischemic ulceration or

‣ Rutherford Classification 6, ischemic gangrene

• Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.

• Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.

• Subject is willing and able to sign the informed consent form.

• Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.

• Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.

• Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).

• Stable glycemic control, HbA1C \< 10% (\<269mg/dL)

⁃ Subjects requiring dialysis may be included, provided they meet all the following requirements:

∙ On dialysis for \> 6 months

‣ Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis

‣ Serum albumin \> 30 g/liter

‣ BMI \> 20