Status:
COMPLETED
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Iliac Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00896337
Start Date
May 1 2009
End Date
December 1 2013
Last Update
May 7 2015
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Hospital
Tucson, Arizona, United States, 85710
2
Brandon Regional Hospital
Brandon, Florida, United States, 33511
3
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
4
Mediquest Research at Munroe Regional Medical Center
Ocala, Florida, United States, 34471