S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease

You may not qualify if:

• Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days.
• Receiving dialysis or immunosuppressant therapy.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure where complete resolution of the thrombus was not achieved.
• Recent stroke within past 90 days.
• Femoral, iliac or aortic aneurysm or aneurysm in the SFA or popliteal artery within past 5 years.
• Required stent placement via a popliteal approach.
• Required stent placement across or within 0.5 cm of the SFA / PFA bifurcation.
• Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as severe calcification which is resistant to stenting, or for in-stent restenosis.
• Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
• Previously deployed stent within the SFA of the target limb.
• Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.
• Presence of thrombus prior to crossing the lesion
• Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
• Serum creatinine level \>/= 2.5 mg/dl at time of screening visit
• Known or suspected active infection at the time of the procedure
• +10 more criteria