Talent Aortic Cuff Stent Graft System Compassionate Use Registry



Status:No longer available
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2002
End Date:April 2012

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Compassionate Use of the TALENT Aortic Cuff in the Treatment of Patients Previously Treated With the AneuRx Stent Graft System With Sub-Optimal Stent Graft Outcomes

An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who
have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for
treatment with an AneuRx Aortic Cuff.

The primary purpose of this registry is to provide an endovascular means of treatment for
those patients experiencing a sub-optimal outcome related to the implanted AneuRx bifurcated
stent graft and who are not deemed suitable candidates for treatment with an AneuRx Aortic
Cuff. A sub-optimal outcome is defined as either a Type I or Type III endoleak and/or an
inadequate seal zone (< 1 cm). For Registry purposes, a Type III endoleak will be defined as
a proximal modular endoleak.

Inclusion Criteria:

- Patient >= 18 years of age

- Patient has a serious disease or condition

- No generally acceptable alternative for treating patient is available

- Patient has had the AneuRx stent graft system implanted >= 30 days

- Patient has suboptimal outcome with the AneuRx stent graft system as evidenced by one
or more of the following:

- Type I endoleak

- Type III endoleak (Proximal, modular)

- Loss of seal zone

- Proximal aortic neck diameter >= 14mm and <= 30mm

- Angle between axis of the suprarenal aorta and aneurysm neck is <= 60 degrees

- Patient is able and willing to be available for 12,24,26,48 and 60 months
post-procedure

Exclusion Criteria:

- Patient is pregnant of lactating

- Arterial access cannot be crossed with a delivery system

- Excessive vessel tortuosity

- Excessive aortic calcification

- AneuRx stent graft system implanted within the last 30 days
We found this trial at
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Oakland, California 94611
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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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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740 South Limestone Street
Lexington, Kentucky 40536
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Ocala, Florida 34471
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Albuquerque, New Mexico 87108
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Asheville, North Carolina 28801
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Atlanta, Georgia 30324
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Charlotte, North Carolina 28203
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Clackamas, Oregon 97015
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Clearwater, Florida 33756
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Colorado Springs, Colorado 80907
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Columbia, South Carolina 29204
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Des Moines, Iowa 50314
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Gainesville, Florida 32605
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Harlingen, Texas 78550
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Harrisburg, Pennsylvania 17101
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Houston, Texas 77030
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Houston, Texas 77090
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Jackson, Mississippi 39202
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Jackson, Mississippi 39202
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Kansas City, Missouri 64111
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5101 South Willow Springs Road
La Grange, Illinois 60525
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611 Saint Landry Street
Lafayette, Louisiana 70506
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Lawrenceville, Georgia 30045
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Lebanon, New Hampshire 03756
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Louisville, Kentucky 40207
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Meridian, Mississippi 39301
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Milwaukee, Wisconsin 53215
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Montgomery, Alabama 36116
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Philadelphia, Pennsylvania 19102
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Philadelphia, Pennsylvania 19146
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Richmond, Virginia 23294
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San Jose, California 95128
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Sioux Falls, South Dakota 57108
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St. Claire Shores, Michigan 48081
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St. Cloud, Minnesota 56303
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St. Joseph, Michigan 49085
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St. Louis, Missouri 63108
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St. Louis, Missouri 63141
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St. Paul, Minnesota 55105
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Tampa, Florida 33612
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Union City, California 94587
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Utica, New York 13502
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Washington, District of Columbia 20010
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West Columbia, South Carolina 29169
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929 N St Francis St
Wichita, Kansas 67214
(316) 268-5775
Via Christi Regional Medical Center Via Christi Health's rich history of serving the people of...
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Worcester, Massachusetts 01655
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