dance partner: inflammatory biomarker analysis by femoropopliteal revascularization method and treatment outcomes

Conditions: Peripheral Arterial Disease

Summary: 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.

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.

Eligibility criteria:
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.)