New device aims to bypass leg blockages without open surgery

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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