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

This is a prospective, multi-center, observational registry to document the baseline, 24-hour
and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after
femoropopliteal angioplasty or atherectomy-based revascularization procedures.

1. To observe the femoropopliteal revascularization outcomes post-angioplasty and/or
atherectomy and to observe potential correlation between patency outcomes and the levels
of MCP-1, C-reactive protein and MMP-9 from baseline to 24 hours and 30 days
post-procedure.

2. To provide a comparator dataset to the investigational DANCE trial, which has the same
enrollment criteria as this observational trial but includes the investigational use of
a local drug therapy to limit inflammation caused by mechanical revascularization.

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.)