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

A Boston Scientific Trial of the 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.

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