TANGO: Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee

⁃ Screening Criteria:

• Age ≥18 years and \<90 years

• Patient has been informed of the nature of the study, agrees to participate and has signed an IRB approved consent form

• Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a highly effective method of birth control (See Section 12.2) one month preceding and 12 months following study treatment

• Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 3, 4 or 5

• Life expectancy \>1 year in the Investigator's opinion

⁃ Angiographic Criteria:

• Target vessel(s) diameter ≥2 mm and ≤8 mm

• Single or multiple atherosclerotic lesion(s) ≥70% in at least one below-knee popliteal or tibial target vessel including the tibioperoneal trunk that totals up to no greater than 30 cm in length (with no greater than 5 cm length of contiguous intervening normal artery), with possible extension into the popliteal artery distal to the center of the knee joint space (the P3 segment)

• Successful revascularization of the TL with less than 30% residual stenosis, run-off down to the foot and direct in-line flow to any foot wound, if a wound is present at baseline