PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

Inclusion Criteria: * Willing and able to provide informed consent * Age 18 or older * Rutherford Classification of 3-5 * Lesions ≥10cm in length considered to be: * Chronic total occlusion (100% stenosis) * Diffuse stenosis (\>50% stenosis) with moderate to heavy calcification * In-stent restenosis (\>50% stenosis) * Proximal and distal target vessels are 4.8 - 7.5 mm in diameter * Orifice and proximal 1cm of SFA is patent * Patent popliteal artery 3cm proximal to tibial plateau * At least 1 patent tibial artery to the foot * Patent femoral vein Exclusion Criteria: * History of deep vein thrombosis * Has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated * Has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications * Documented in-sensitivity to anti-platelet medication * Has a known or previous coagulopathy * Pregnant or lactating * Untreated flow-limiting aortoiliac occlusive disease * Has renal failure (GFR \< 30mL/min) * Major distal amputation (above the transmetatarsal) in the study or non-study limb * Patient has had a procedure on the target limb within 30 days * Previous bypass surgery on the target limb * Bypass length required is greater than 35cm