Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
NCT ID: NCT00522535
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2006-04-30
2020-07-31
Brief Summary
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Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.
Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.
Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open Surgical Repair
Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.
Open surgical repair
Open surgical repair of abdominal aortic aneurysm
Endovascular Repair
Endovascular treatment arm of 160 patients having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. Use of stent grafts in aortic angles greater than 60° has not been approved for other devices available in the US. As a result, a minimum of 120 patients in this arm will have an aortic angle between 60° and 90°.
Patient recruitment completed; 5-year follow-up evaluations continue.
Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Continued Access
Endovascular treatment arm of 50 patients maximum having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. This Arm will provide active sites with ongoing device access while FDA reviews the PMA.
Patient recruitment completed; 5-year patient follow-ups continue.
Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Interventions
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Open surgical repair
Open surgical repair of abdominal aortic aneurysm
Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.
Exclusion Criteria
* Life expectancy less than 2 years,
* Pregnant,
* Religious cultural or other objection to the receipt of blood or blood products,
* Unwilling to comply with follow-up schedule,
* Unwillingness or inability to provide informed consent to both trial and procedure.
* Patients not expected to live more than 2 years from enrollment
* Patient has a ruptured aneurysm
* Aneurysm extends above renal arteries
* Proximal neck of aneurysm has significant loose thrombus associated with it
* Patient with an acute or chronic aortic dissection or mycotic aneurysm
* Patient has current non-localized infection (may be recruited following remission of the infection)
* Patient is allergic to device materials
* Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl
* Patient is clinically and morbidly obese such that imaging would be severely adversely affected
* Patient has renal failure (serum creatinine \> 2.5 mg/dL)
* Patient has an uncorrectable bleeding abnormality
* Patient has unstable angina
* Patient is receiving dialysis:
* Inflammatory aneurysm
* MI in last 6 months
* End stage COPD
* Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome)
* Significant (\>80%) renal artery stenosis which cannot be readily treated
21 Years
ALL
No
Sponsors
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Lombard Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Fillinger, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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UAB Vascular Surgery
Birmingham, Alabama, United States
University of Arizona, Department of Surgery
Tucson, Arizona, United States
Long Beach VA Healthcare System
Long Beach, California, United States
UCSF Division of Vascular Surgery
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
Baptist Hospital of Miami, Cardiac & Vascular Institute
Miami, Florida, United States
Macon Cardiovascular Institute
Macon, Georgia, United States
Methodist Heart Lung & Vascular Institute
Peoria, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan, Department of Vascular Surgery
Ann Arbor, Michigan, United States
Michigan Vascular Group
Flint, Michigan, United States
Abbott Northwestern / MHIF
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Dartmouth - Hitchcock Medical
Lebanon, New Hampshire, United States
Englewood Hospital & Medical Center
Englewood, New Jersey, United States
Newark-Beth Israel Medical Center
Newark, New Jersey, United States
Albany Medical Center
Albany, New York, United States
New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery
New York, New York, United States
Jobst Vascular Center
Toledo, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Moffitt Heart and Vascular Group
Wormleysburg, Pennsylvania, United States
Sanford Clinic Clinical Research
Sioux Falls, South Dakota, United States
University of Tennessee
Chattanooga, Tennessee, United States
DeBakey Heart Center, Methodist Hospital
Houston, Texas, United States
Sentara Heart Hospital - Vascular & Transplant Specialists
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States
Countries
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References
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Wang S, Hicks CW, Malas MB. Neck diameter and inner curve seal zone predict endograft-related complications in highly angulated necks after endovascular aneurysm repair using the Aorfix endograft. J Vasc Surg. 2018 Mar;67(3):760-769. doi: 10.1016/j.jvs.2017.07.114. Epub 2017 Sep 21.
Malas MB, Hicks CW, Jordan WD Jr, Hodgson KJ, Mills JL Sr, Makaroun MS, Belkin M, Fillinger MF; PYTHAGORAS Investigators. Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks. J Vasc Surg. 2017 Jun;65(6):1598-1607. doi: 10.1016/j.jvs.2016.10.120. Epub 2017 Feb 9.
Malas MB, Jordan WD, Cooper MA, Qazi U, Beck AW, Belkin M, Robinson W, Fillinger M. Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial. J Vasc Surg. 2015 Nov;62(5):1108-17. doi: 10.1016/j.jvs.2015.05.042. Epub 2015 Aug 28.
Related Links
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Lombard Medical Technologies Inc. Homepage
Other Identifiers
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PYTHAGORAS
Identifier Type: -
Identifier Source: org_study_id