EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
ORION
A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
1 other identifier
interventional
125
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2009
Longer than P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 8, 2009
CompletedFirst Posted
Study publicly available on registry
May 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedResults Posted
Study results publicly available
July 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 7, 2015
April 1, 2015
2.3 years
May 8, 2009
April 10, 2012
April 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Device- and/or Procedure-related Major Adverse Events (MAE)
MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months
9 Months
Secondary Outcomes (63)
Death
30 Days
Death
9 Months
Death
1 Year
Death
2 Years
Death
3 Years
- +58 more secondary outcomes
Study Arms (1)
ORION
EXPERIMENTALAll subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
Interventions
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.
Eligibility Criteria
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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
St. Joseph's Hospital
Tucson, Arizona, 85710, United States
Brandon Regional Hospital
Brandon, Florida, 33511, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Mediquest Research at Munroe Regional Medical Center
Ocala, Florida, 34471, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 46805, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Parkview Hospital-Parkview Research Center
Fort Wayne, Indiana, 46805, United States
St. Vincent's Hospital
Indianapolis, Indiana, 46290, United States
Trinity Terrace Park
Davenport, Iowa, 52803, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
North Memorial Medical Center
Robbinsdale, Minnesota, 55422, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Mid-Carolina Cardiology - Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Wake Medical Center
Raleigh, North Carolina, 27610, United States
MeritCare Hospital
Fargo, North Dakota, 58102, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
UPMC - Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
York Hospital
York, Pennsylvania, 17405, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
St. Thomas Research Institute
Nashville, Tennessee, 37205, United States
VA North Texas Health Care System
Dallas, Texas, 75216, United States
Baptist Hospital of San Antonio
San Antonio, Texas, 78205, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Related Publications (1)
Clair DG, Adams J, Reen B, Feldman R, Starr J, Diaz-Cartelle J, Dawkins KD. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial. J Endovasc Ther. 2014 Apr;21(2):213-22. doi: 10.1583/13-4560.1.
PMID: 24754280DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela Schutt
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Pamela G. Grady, Ph.D.
Boston Scientific Corporation
- PRINCIPAL INVESTIGATOR
Daniel G Clair, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2009
First Posted
May 11, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2011
Study Completion
December 1, 2013
Last Updated
May 7, 2015
Results First Posted
July 3, 2012
Record last verified: 2015-04