Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease (DANCE)

This is an interventional treatment trial for Peripheral Arterial Diseases focused on measuring Adventitia, Peripheral Artery Disease, Restenosis, Inflammation, Anti-Inflammatory, Dexamethasone Read More

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.)