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

Completed · Phase 3

Conditions studied: Iliac Artery Stenosis

In brief

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.

Key facts

Study ID

NCT00896337

Run by

Boston Scientific Corporation

People needed

125

Starts

2009-05-01

Expected to finish

2013-12-01

Last updated by the study team

2015-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Joseph's Hospital — Tucson, Arizona, United States
• Brandon Regional Hospital — Brandon, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Mediquest Research at Munroe Regional Medical Center — Ocala, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Wellstar Kennestone Hospital — Marietta, Georgia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Parkview Hospital-Parkview Research Center — Fort Wayne, Indiana, United States
• St. Vincent's Hospital — Indianapolis, Indiana, United States
• Trinity Terrace Park — Davenport, Iowa, United States
• University of Michigan — Ann Arbor, Michigan, United States
• North Memorial Medical Center — Robbinsdale, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• Mid-Carolina Cardiology - Presbyterian Hospital — Charlotte, North Carolina, United States
• Wake Medical Center — Raleigh, North Carolina, United States
• MeritCare Hospital — Fargo, North Dakota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Grant Medical Center — Columbus, Ohio, United States
• University of Oklahoma Health Science Center — Oklahoma City, Oklahoma, United States
• UPMC - Shadyside Hospital — Pittsburgh, Pennsylvania, United States
• York Hospital — York, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Erlanger Medical Center — Chattanooga, Tennessee, United States
• St. Thomas Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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