A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System

Inclusion criteria

• The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
• The subject is ≥ 21 years old.
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
• The subject has lifestyle-limiting claudication or mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss).
• The target lesion has angiographic evidence of stenosis or restenosis ≥50% or occlusion in the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting.
• The target vessel reference diameter is (by visual estimate) appropriate for treatment with available stent diameters of 6.0 and 7.0 mm.
• There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

Exclusion criteria

• The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
• The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).
• The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medication, nickel, titanium or tantalum.
• The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
• The subject has a history of bleeding diatheses of coagulopathy.
• The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
• The subject has concomitant hepatic insufficiency,thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
• The subject is receiving dialysis or immunosuppressive therapy.
• The subject is participating in an investigational drug or another investigational device study.
• The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be noncompliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.
• The subject has extensive peripheral vascular disease, which,in the opinion of the investigator, precludes safe insertion of an introducer sheath.
• The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
• The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
• The subject is diagnosed with septicemia at the time of the study procedure.
• Subjects with a stent previously implanted into the target lesion. A target vessel with a previously placed stent is permitted as long as the subject device will not come into contact with the previously placed stent during treatment of the target lesion.
• Lesions requiring the use of more than one investigational stent.
• Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days.