EverFlex Post Approval Study

Exclusion Criteria

• •1. Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
• •2. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, contrast media or any other drug used in study according to the protocol.
• •3. Has known hypersensitivity to nickel-titanium.
• •4. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion.
• •5. Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures.
• •6. Has life expectancy of less than 1 year.
• •7. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure.
• •8. Has previously been enrolled in the DURABILITY PAS study.
• •9. Has received endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure.
• •10. Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure.
• •11. Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
• •12. Has any co-morbid condition that precludes endovascular treatment.
• •1. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s).
• •2. Presence of significant (\> 50% stenosis or occlusion) ipsilateral common femoral stenosis.
• •3. Aneurysmal target vessel.
• •4. Presence of an acute intraluminal thrombus at the proposed lesion site.
• •5. Perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to start of PTA procedure.
• •6. Focal popliteal disease in the absence of femoral disease.