• Patency, defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion at 12 months follow-up, and no further clinically driven target vessel revascularization performed in the interim. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• 30-day freedom from all causes of death, index limb amputation and TLR. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  

• 30 day death [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  
• 30 day amputation [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  
• 30 day TVR [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  
• 12 month Target Vessel Revascularization (TVR) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  
• Rutherford classification change at 12 months [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  

Inclusion Criteria:

• Age >/= 30 years
• For women of child bearing potential, a pregnancy test within 7 days prior to index procedure (the test results must be negative to be eligible).
• Symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4) with a resting ABI </= 0.8.
• A single superficial femoral artery lesion with > 50% stenosis or total occlusion.
• Stenotic lesion or occluded length within the same vessel (one long or multiple serial lesions) >/= 4.0 cm to </= 15.0 cm. The stenosis must be treatable with no more than two stents, minimizing the stent overlap whose combined length </= 170 mm.
• Reference vessel diameter (RVD) >/= 4.0 mm and </ 6.0 mm by visual assessment.
• All lesions are to be located at least three centimeters proximal to the superior edge of the patella.
• Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (< 50% stenosis) to the ankle or foot.
• The guidewire is across the target lesion(s) and located intraluminally within the distal vessel.
• Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined > 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion.
• A patient with bilateral obstructive SFA disease is eligible for enrollment into the study.
• Eligibility for standard surgical repair, if necessary.
• A patient who requires a coronary intervention, should have it performed at least 7 days prior to the treatment of the target lesion.
• Patient or authorized representative must provide written informed consent and written HIPAA authorization prior to initiation of study procedures.
• Patient must be willing to comply with the specified follow-up evaluation schedule.

Exclusion Criteria:

• Concomitant hepatic insufficiency [SGOT and / or SGPT > two (2) times ULN] at time of screening visit.
• Thrombophlebitis, uremia, or deep venous thrombus, within past 1 month.
• 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 3 months.
• Femoral, iliac or aortic aneurysm or aneurysm in the SFA or popliteal artery.
• 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.
• Required stent placement within 1 cm of a previously deployed stent.
• 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
• Bleeding diathesis
• Presence of an aortic, iliac or femoral artificial graft
• Life expectancy less than one year, or any other factors preventing clinical followup.
• Use of cryoplasty, laser, or atherectomy devices on the target vessel at the time of index procedure
• In-stent restenotic lesions at time of procedures.