Introduction - Patients with lower extremity ischemia due to long segment superficial femoral artery (SFA) occlusive disease do not have an optimal treatment solution today. Percutaneous endovascular revascularization lacks durability in these long segments while surgical bypass, the current gold-standard for durability, is associated with greater morbidity, longer length of stay and longer recovery times. Percutaneous femoral popliteal bypass (PQB) is an emerging treatment option that combines the safety and minimally invasive benefits of a percutaneous procedure with the long-term durability of surgical bypass. This trial evaluates the safety and effectiveness of the PQ Bypass System to treat long-segment SFA occlusions via a fully percutaneous bypass utilizing the femoral vein as a partial conduit. Methods - This is a prospective, multi-center, non-randomized, single-arm trial. Primary 6-month safety endpoint: Major Adverse Events (MAE); defined as death, target vessel revascularization and major amputation of the target limb. Primary performance endpoint: primary patency at 6 months; defined as Peak Systolic Velocity Ration (PSVR) of less than or equal to 2.5. A proprietary crossing device and proprietary snare are used to create anastamoses between the artery and vein at the proximal and distal margins of the SFA occlusion. A series of proprietary stent grafts are then deployed in continuous overlapping fashion to create an SFA to popliteal artery bypass, resulting in a large lumen endograft bypass that delivers unobstructed pulsatile flow to the popliteal artery. Results - 60 subjects have been enrolled in the Primary Analysis Cohort and 60 treated. Mean age was 64 ± 9 years (68/68), 83.3% (50/60) of patients were male. The PQ Bypass System successfully delivered guidewires and placed stent grafts and thus completed a percutaneous fem-pop bypass in 98.3% (59/60) of cases. Independent Core Lab-assessed screening CTAs indicate a mean lesion length of 28.6 ± 5.1 (60/60), with 96.7% (58/60) considered to be chronic total occlusion and 33.3% (20/60) having previous peripheral artery revascularization or surgery. At 6 months, the primary safety and efficacy endpoints were met, respectively, at 3.4% MAE with 0 cases of DVT and 84.7% primary patency. 91.2% of subjects experienced at least a 2 class improvement in Rutherford Class at 6 months. Conclusion - For patients with SFA occlusive disease, percutaneous bypass with the PQ Bypass System using the femoral vein as a conduit may prove to be an important step forward in providing an optimal treatment solution.