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