Talent Aortic Cuff Stent Graft System Compassionate Use Registry
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
1 other identifier
expanded_access
N/A
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedNovember 2, 2021
October 1, 2021
December 21, 2007
October 27, 2021
Conditions
Keywords
Interventions
Endovascular Aneurysm Repair
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Baptist Hospital
Montgomery, Alabama, 36116, United States
Kaiser
Oakland, California, 94611, United States
O'Connor Hospital
San Jose, California, 95128, United States
Kaiser Hayward
Union City, California, 94587, United States
Penrose Healthcare
Colorado Springs, Colorado, 80907, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Washington Hospital
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33757, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
University of Florida
Gainesville, Florida, 32610, United States
Munroe Regional Medical Center
Ocala, Florida, 34474, United States
JA Haley Veterans Hospital
Tampa, Florida, 33612, United States
St. Joseph's Hospital
Atlanta, Georgia, 30342, United States
Gwinnett Hospital
Lawrenceville, Georgia, 30045, United States
LaGrange Memorial Hospital
La Grange, Illinois, 60525, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Via Christi Regional Medical center
Wichita, Kansas, 67214, United States
University of Kentucky medical Center
Lexington, Kentucky, 40536, United States
Baptist Hospital
Louisville, Kentucky, 40207, United States
Southwest Medical Center
Lafayette, Louisiana, 70506, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Bon Secours Cottage Health Center
Saint Clair Shores, Michigan, 48081, United States
Lakeland Regional Medical Center
Saint Joseph, Michigan, 49085, United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Health Easst St. Joseph's Hospital
Saint Paul, Minnesota, 55105, United States
CV Surgical Clinic
Jackson, Mississippi, 39202, United States
St. Dominic-Jackson
Jackson, Mississippi, 39202, United States
Jeff Anderson Regional Medical Center
Meridian, Mississippi, 39301, United States
St. Luke's
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756, United States
NMVA Healthcare
Albuquerque, New Mexico, 87108, United States
St. Luke's Healthcare
Utica, New York, 13502, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
The Sanger Clinic-Carolinas Medical
Charlotte, North Carolina, 28203, United States
Kaiser Sunnyside
Clackamas, Oregon, 97015, United States
Pinnacle Health Hospital
Harrisburg, Pennsylvania, 17101, United States
Hahnemann Univeristy Hospital
Philadelphia, Pennsylvania, 19102, United States
Graduate Hospital
Philadelphia, Pennsylvania, 19146, United States
Providence Hospital
Columbia, South Carolina, 29204, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
North Central heart Institute
Sioux Falls, South Dakota, 57108, United States
Harlingen Medical Center
Harlingen, Texas, 78550, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Houston Northwest Medical Center
Houston, Texas, 77090, United States
University of Vermont
Burlington, Vermont, 05402, United States
Henrico Doctors' Hospital
Richmond, Virginia, 23229, United States
St. Luke's medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medtronic CardioVascular
Medtronic Cardiovascular
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 30, 2008
Last Updated
November 2, 2021
Record last verified: 2021-10