EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Condition: Iliac Artery Stenosis
MeSH terms: Constriction, Pathologic
Intervention: Epic™ Nitinol Stent System; Anti-platelet therapy; Anti-coagulation therapy
Intervention description: The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.; Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.; Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iliac artery stenosis; claudication; atherosclerotic iliac disease; peripheral vascular disease

Summary:

      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.
    

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