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A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries - NCT00896337-53210(Clinical Trial 290830)



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City:  Milwaukee
State:  
WI
Zip Code: 53210
Conditions: Iliac Stenoses
Purpose: 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.
Study summary:
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
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Data Source: ClinicalTrials.gov
Date Processed: December 15, 2010
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