Talent Aortic Cuff Stent Graft System Compassionate Use Registry
- Conditions
- Abdominal Aortic Aneurysms
- Registration Number
- NCT00604643
- Lead Sponsor
- Medtronic Cardiovascular
- 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.
- 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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
St. Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
St. Cloud Hospital
🇺🇸Saint Cloud, Minnesota, United States
Health Easst St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
CV Surgical Clinic
🇺🇸Jackson, Mississippi, United States
St. Dominic-Jackson
🇺🇸Jackson, Mississippi, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Houston Northwest Medical Center
🇺🇸Houston, Texas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
The Sanger Clinic-Carolinas Medical
🇺🇸Charlotte, North Carolina, United States
Kaiser Sunnyside
🇺🇸Clackamas, Oregon, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Hahnemann Univeristy Hospital
🇺🇸Philadelphia, Pennsylvania, United States
NMVA Healthcare
🇺🇸Albuquerque, New Mexico, United States
St. Luke's Healthcare
🇺🇸Utica, New York, United States
Dartmouth-Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Pinnacle Health Hospital
🇺🇸Harrisburg, Pennsylvania, United States
North Central heart Institute
🇺🇸Sioux Falls, South Dakota, United States
Graduate Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Providence Hospital
🇺🇸Columbia, South Carolina, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
Harlingen Medical Center
🇺🇸Harlingen, Texas, United States
St. Luke's medical Center
🇺🇸Milwaukee, Wisconsin, United States
JA Haley Veterans Hospital
🇺🇸Tampa, Florida, United States
Kaiser
🇺🇸Oakland, California, United States
O'Connor Hospital
🇺🇸San Jose, California, United States
Kaiser Hayward
🇺🇸Union City, California, United States
Penrose Healthcare
🇺🇸Colorado Springs, Colorado, United States
Washington Hospital
🇺🇸Washington, District of Columbia, United States
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
Gwinnett Hospital
🇺🇸Lawrenceville, Georgia, United States
LaGrange Memorial Hospital
🇺🇸La Grange, Illinois, United States
Southwest Medical Center
🇺🇸Lafayette, Louisiana, United States
Via Christi Regional Medical center
🇺🇸Wichita, Kansas, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Lakeland Regional Medical Center
🇺🇸Saint Joseph, Michigan, United States
Jeff Anderson Regional Medical Center
🇺🇸Meridian, Mississippi, United States
Bon Secours Cottage Health Center
🇺🇸Saint Clair Shores, Michigan, United States
Baptist Hospital
🇺🇸Louisville, Kentucky, United States
St. Luke's
🇺🇸Kansas City, Missouri, United States
Henrico Doctors' Hospital
🇺🇸Richmond, Virginia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
University of Kentucky medical Center
🇺🇸Lexington, Kentucky, United States