Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:3/31/2019
Start Date:April 2006
End Date:July 2019

Use our guide to learn which trials are right for you!

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.


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
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
750 Highland Avenue
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
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...
?
mi
from
Portland, OR
Click here to add this to my saved trials
1000 W Carson St
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Baltimore, Maryland 21224
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
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...
?
mi
from
Danville, PA
Click here to add this to my saved trials
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...
?
mi
from
Englewood, NJ
Click here to add this to my saved trials
Flint, Michigan 48507
?
mi
from
Flint, MI
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17104
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Long Beach, California 90822
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, Delaware 19718
?
mi
from
Newark, DE
Click here to add this to my saved trials
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...
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sioux Falls, South Dakota 57117
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Springfield, Illinois 62702
?
mi
from
Springfield, IL
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Wormleysburg, Pennsylvania 17043
?
mi
from
Wormleysburg, PA
Click here to add this to my saved trials