DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes

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 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 < 2years
• 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, drug-coated balloon or stenting of the target lesion
• Contra-indication or known hypersensitivity to contrast media or physician prescribed antiplatelet regimen as applicable
• 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
• 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
• 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.)