EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.

Inclusion Criteria:

• Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
• or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.

Exclusion Criteria:

• Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.