EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.

Eligibility Criteria:
Inclusion Criteria:

* Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4)
* Lifestyle-limiting claudication or rest pain
* De novo or restenotic lesions in the common and/or external iliac artery
* Subjects with bilateral disease may have only one target lesion treated per side
* Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent)
* Length of diseased segment(s) \<=13 cm and treatment is planned with no more than 2 overlapped Epic™ stents
* Baseline diameter stenosis \>= 50% (operator visual assessment)
* Reference vessel diameter \>= 5 mm and \<=11 mm
* At least one sufficient ipsilateral infrapopliteal run-off vessel
* Origin of profunda femoris artery is patent

Exclusion Criteria:

* Target vessel with in-stent restenosis
* Acute critical limb ischemia
* Tissue loss (Rutherford/Becker category 5 or 6)
* Any major amputations to the target limb
* Any minor amputation of the target limb in the last 12 months. If a minor amputation occurred greater than 12 months, stump needs to be completely healed.
* Life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
* Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
* Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
* Platelet count \< 150,000 mm3 or \> 600,000 mm3
* Serum creatinine \> 2.0 mg/dL
* Dialysis-dependent end stage renal disease
* Pregnancy
* Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial
* Known allergy to Nitinol
* Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel
* Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography
* Target lesion is within or near an aneurysm
* Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
* Perforated vessel as evidenced by extravasation of contrast media
* Vascular graft, aneurysm or postsurgical stenosis of the target vessel
* Multiple lesions in the same target vessel unable to be treated with a maximum of two stents