Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

Inclusion Criteria

• •Inclusion Screening Criteria:
• •Age ≥18 years and ≤85 years at study enrollment
• •Subject has been informed of the nature of the study, agrees to participate and has signed an IRB-approved consent form
• •Subject is ambulatory
• •Female subjects 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) for one month preceding and 12 months following study treatment
• •Subject has documented moderate to severe claudication (Rutherford 2-3) or Critical Limb Ischemia (CLI) with rest pain (Rutherford 4) in the target limb due to arterial stenosis within the superficial femoral and/or popliteal artery
• •Life expectancy \>2 years in the Investigator's opinion Angiographic Criteria (Target Lesion Definition)
• •Target vessel reference diameter ≥3 mm and ≤8 mm
• •Single or multiple de novo atherosclerotic or restenotic lesion(s) with ≥70% narrowing in the superficial femoral or popliteal artery meeting the following criteria:
• •* The target lesion must be ≤20 cm in total length
• +26 more criteria