Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization (DANCE)

Inclusion Criteria:

• Patient is > 40 years and < 80 years of age
• Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
• Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
• Patient has a resting ABI of <0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI <0.8
• Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a >50% stenosis
• Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis <30% as compared to the reference vessels
• Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
• Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)

Exclusion Criteria:

• Patient is simultaneously participating in another investigational drug or device study
• Patient is pregnant or breast-feeding
• Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy
• Patient has end-stage renal disease and chronic kidney disease (eGFR<30)
• Patient has an active infection
• Patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other glucocorticoids
• Patient has a life expectancy of less than one year