In-Stent Restenosis Post-Approval Study

Inclusion Criteria:

- Patient has a previously implanted (> 30 days) non-covered stent(s) located in the SFA

- Patient has life-style limiting claudication, resting leg pain or minor tissue loss
(Rutherford Category 2 - 5)

- Patient demonstrates an Ankle Brachial Index (ABI) <=0.9. If ABI >0.9 or not
measurable, patient is eligible for study if Toe Brachial Index is <=0.5

- Patient has >=50% in-stent restenosis and / or an occlusion in a previously implanted
(>30 days) non-covered stent(s) located in the superficial femoral artery defined as
beginning at least 1cm below the origin of the profunda femoris artery and ending at
least 1cm above the intercondylar notch.

- Patient has a maximum total lesion length of 270mm, consisting of in-stent and
adjacent occlusive disease

- Patient has a reference vessel diameter between 4.0 and 6.5mm

- Patient has at least one patent infrapopliteal runoff vessel (<50% stenosis) not
requiring reintervention

- Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

- Patient has a known allergy to stent graft components (nickel-titanium or
expanded-polytetrafluoroethylene)

- Patient has a known intolerance to anticoagulation or antiplatelet therapy

- Patient has known coagulation disorder, including hypercoagulability.

- Patient has major distal amputation (above the transmetatarsal)

- Patient has any previous surgery in the target vessel

- Patient has had previous target vessel in-stent restenosis treated by relining with
another stent

- Patient has untreated flow-limiting aortoiliac stenotic disease

- Note: Additional Exclusion Criteria may apply