Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:3/30/2013
Start Date:April 2006
End Date:September 2016
Contact:Tim C. Vander Meulen
Email:PYTHAGORAS@LombardMedical.com
Phone:480-289-7888

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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 hypotheses:

Efficacy:

The twelve month, all cause mortality rate in the Aorfix™ group will be non-inferior to the
twelve month, all cause mortality rate in the 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 control group.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
38
sites
Newark, Delaware 19718
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Ft. Lauderdale, FL
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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750 Highland Avenue
Madison, Wisconsin 53792
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Madison, WI
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920 Madison Ave
Memphis, Tennessee 38163
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Memphis, TN
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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St. Louis, MO
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albany, NY
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Ann Arbor, MI
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Baltimore, Maryland 21224
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Baltimore, MD
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Birmingham, Alabama 35294
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Birmingham, AL
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Englewood, NJ
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Flint, Michigan 48507
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Harrisburg, Pennsylvania 17104
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Houston, TX
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Lebanon, New Hampshire 03756
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Long Beach, California 90822
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Macon, Georgia 31201
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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New York, NY
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Newark, NJ
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Norfolk, VA
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Peoria, IL
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San Francisco, California 94143
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Sioux Falls, South Dakota 57117
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Spokane, Washington 99204
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Spokane, WA
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Springfield, Illinois 62702
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Toledo, Ohio 43606
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Torrance, California 90509
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Tucson, AZ
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Wormleysburg, Pennsylvania 17043
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