Talent Aortic Cuff Stent Graft System Compassionate Use Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00604643
Expanded Access Status : No longer available
First Posted : January 30, 2008
Last Update Posted : August 3, 2015
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms Device: TALENT Aortic Cuff Abdominal Stent Graft

Detailed Description:
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.

Study Type : Expanded Access
Official Title: 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
Study Start Date : October 2002
Actual Primary Completion Date : July 2008
Estimated Study Completion Date : April 2012

Intervention Details:
  • Device: TALENT Aortic Cuff Abdominal Stent Graft
    Endovascular Aneurysm Repair

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00604643

  Hide Study Locations
United States, Alabama
Baptist Hospital
Montgomery, Alabama, United States, 36116
United States, California
Oakland, California, United States, 94611
O'Connor Hospital
San Jose, California, United States, 95128
Kaiser Hayward
Union City, California, United States, 94587
United States, Colorado
Penrose Healthcare
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Washington Hospital
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33757
North Florida Regional Medical Center
Gainesville, Florida, United States, 32605
University of Florida
Gainesville, Florida, United States, 32610
Munroe Regional Medical Center
Ocala, Florida, United States, 34474
JA Haley Veterans Hospital
Tampa, Florida, United States, 33612
United States, Georgia
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
Gwinnett Hospital
Lawrenceville, Georgia, United States, 30045
United States, Illinois
LaGrange Memorial Hospital
La Grange, Illinois, United States, 60525
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50314
United States, Kansas
Via Christi Regional Medical center
Wichita, Kansas, United States, 67214
United States, Kentucky
University of Kentucky medical Center
Lexington, Kentucky, United States, 40536
Baptist Hospital
Louisville, Kentucky, United States, 40207
United States, Louisiana
Southwest Medical Center
Lafayette, Louisiana, United States, 70506
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Bon Secours Cottage Health Center
St. Claire Shores, Michigan, United States, 48081
Lakeland Regional Medical Center
St. Joseph, Michigan, United States, 49085
United States, Minnesota
St. Cloud Hospital
St. Cloud, Minnesota, United States, 56303
Health Easst St. Joseph's Hospital
St. Paul, Minnesota, United States, 55105
United States, Mississippi
CV Surgical Clinic
Jackson, Mississippi, United States, 39202
St. Dominic-Jackson
Jackson, Mississippi, United States, 39202
Jeff Anderson Regional Medical Center
Meridian, Mississippi, United States, 39301
United States, Missouri
St. Luke's
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
NMVA Healthcare
Albuquerque, New Mexico, United States, 87108
United States, New York
St. Luke's Healthcare
Utica, New York, United States, 13502
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
The Sanger Clinic-Carolinas Medical
Charlotte, North Carolina, United States, 28203
United States, Oregon
Kaiser Sunnyside
Clackamas, Oregon, United States, 97015
United States, Pennsylvania
Pinnacle Health Hospital
Harrisburg, Pennsylvania, United States, 17101
Hahnemann Univeristy Hospital
Philadelphia, Pennsylvania, United States, 19102
Graduate Hospital
Philadelphia, Pennsylvania, United States, 19146
United States, South Carolina
Providence Hospital
Columbia, South Carolina, United States, 29204
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
North Central heart Institute
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Harlingen Medical Center
Harlingen, Texas, United States, 78550
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Houston Northwest Medical Center
Houston, Texas, United States, 77090
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05402
United States, Virginia
Henrico Doctors' Hospital
Richmond, Virginia, United States, 23229
United States, Wisconsin
St. Luke's medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Medtronic Endovascular
Study Director: Medtronic CardioVascular Medtronic Cardiovascular

Responsible Party: Medtronic Endovascular Identifier: NCT00604643     History of Changes
Other Study ID Numbers: Investigational Plan #025
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015

Keywords provided by Medtronic Endovascular:
Abdominal Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases