Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysms

In brief

Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°. 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.

Key facts

Study ID

NCT00522535

Run by

Lombard Medical

People needed

230

Starts

2006-04-01

Expected to finish

2020-07-01

Last updated by the study team

2021-10-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or
• Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.

You may not qualify if…

• Less than 21 years of age,
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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