Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

Inclusion Criteria: * Screening Criteria * Male or non-pregnant female ≥18 years of age * Rutherford Clinical Category 2-4 * Clinical diagnosis of PAD requiring revascularization, secondary to atherosclerosis affecting a lower limb * Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen * Procedural Criteria * De novo or nonstented restenotic lesions \>90 days from prior angioplasty and/or atherectomy, at least 3 cm from any previously placed stent or vascular surgery site * \>70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm length of contiguous intervening normal artery) in the superficial femoral and/or popliteal artery (between the profunda and tibioperoneal trunk) * Reference vessel diameter ≥3mm and ≤ 8mm * Successful wire crossing of lesion * A patent artery proximal to the index lesion free from significant stenosis (significant stenosis is defined as \>50% in iliac or \>30% stenosis in common femoral artery) as confirmed by angiography (treatment of target lesion after successful treatment of iliac or common femoral artery lesions is acceptable) Exclusion Criteria: * Screening Criteria * Pregnant, nursing or planning on becoming pregnant in \< 2 years * Life expectancy of \<2 years * Known active malignancy * History of solid organ transplantation * Patient actively participating in another investigational device or drug study * History of hemorrhagic stroke within 3 months * Previous or planned surgical or interventional procedure within 30 days of index procedure * Chronic renal insufficiency with eGFR \<29 * Prior bypass surgery, stenting of the target lesion * Inability to take required study medications * Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, or Physician prescribed antiplatelet regimen as indicated * Systemic fungal infection * Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment * Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset * Acute limb ischemia * Prior participation of the index limb in the current study (contralateral treatment is allowed) * Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation) * Patient is receiving steroids already, however locally acting inhaled steroids for asthma treatment do not exclude patients from the trial * Procedural Criteria * Lesions extending into the trifurcation or above the profunda * Heavy eccentric or moderate circumferential calcification at index lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Catheter needle through the vessel wall * Lesion length is \>15 cm as measured from proximal normal vessel to distal normal vessel, or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured * Inadequate distal outflow defined as absence of at least one patent tibial artery (no lesion \>50% stenosis) with flow into the foot * Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent, drug-coated balloon, cryoplasty, etc.)