A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries - NCT00896337-53210 (Clinical Trial 290830)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy290830.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53210 |
| Conditions: |
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Iliac Stenoses |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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:
- Previous stent placement in the target vessel
- Acute critical limb ischemia
- Tissue loss (Rutherford/Becker category 5 or 6)
- History of amputation in the lower extremities
- 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 other arterial 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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| Study is available at: |
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St. Joseph Regional Medical Center
Milwaukee, WI 53210
United States
Primary Contact:
Jennifer Hansen
Email: Jennifer.Hansen@bsci.com
Phone: 651-581-4631 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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