Clinical Research Directory

Inclusion Criteria: * Willing and able to provide informed consent * Age 18 or older * Rutherford Classification of 3-5 * Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath * Femoro-popliteal lesions ≥10 cm 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 5.4-7.0 mm in diameter * Orifice and proximal 1 cm of SFA is patent * Patent popliteal artery 3 cm proximal to tibial plateau * At least 1 patent tibial artery to the foot * Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein * Subject has \> one year life expectancy Exclusion Criteria: * Bypass length required \> 30 cm * History of deep vein thrombosis * Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment; * Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months * Pregnant or nursing * Untreated flow-limiting aortoiliac occlusive disease * Has renal failure (eGFR \< 30mL/min) * Major distal amputation (above the transmetatarsal) in the study or non-study limb * Patient has had a revascularization procedure on the target limb within 30 days * Patient has a planned amputation of the target limb * Previous bypass surgery on the target limb * Patient is participating in another clinical study for which follow-up is currently on going. * Patient has a condition that in the view of the investigator precludes participation in this study