Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II

This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.

Inclusion Criteria:

• Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
• Symptomatic femoral-popliteal atherosclerosis.
• Willing to comply with all follow-up evaluations at the specified times.
• Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

• Previously implanted stent(s) or stent graft(s) in the target vessel.
• Planned use of devices other than angioplasty balloons during procedure.
• Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
• Life expectancy of less than 12 months.
• Symptomatic femoral disease in the opposite limb.