The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study

Inclusion criteria

• . Patient is male or female, with age \> 18 and ≤ 90 years at date of enrollment.
• . Patient provides written informed consent before any study-specific investigations or procedures.
• . Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
• . Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
• . Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery.
• . Patient has PAD classified as Rutherford classification 2, 3 or 4.
• . Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be \<0.70; or (ii) Normal ABI with angiographic, ultrasound, MRA, or CT evidence of ≥ 60% diameter stenosis.
• . Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.

Exclusion criteria