Talent Aortic Cuff Stent Graft System Compassionate Use Registry

NO_LONGER_AVAILABLE

Conditions studied: Abdominal Aortic Aneurysms

In brief

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.

Key facts

Study ID

NCT00604643

Run by

Medtronic Cardiovascular

Last updated by the study team

2021-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Baptist Hospital — Montgomery, Alabama, 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
• Hartford Hospital — Hartford, Connecticut, United States
• Washington Hospital — Washington D.C., District of Columbia, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• North Florida Regional Medical Center — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• JA Haley Veterans Hospital — Tampa, Florida, United States
• St. Joseph's Hospital — Atlanta, Georgia, United States
• Gwinnett Hospital — Lawrenceville, Georgia, United States
• LaGrange Memorial Hospital — La Grange, Illinois, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Via Christi Regional Medical center — Wichita, Kansas, United States
• University of Kentucky medical Center — Lexington, Kentucky, United States
• Baptist Hospital — Louisville, Kentucky, United States
• Southwest Medical Center — Lafayette, Louisiana, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Bon Secours Cottage Health Center — Saint Clair Shores, Michigan, United States
• Lakeland Regional Medical Center — Saint Joseph, Michigan, United States
• St. Cloud Hospital — Saint Cloud, Minnesota, United States

Full record on ClinicalTrials.gov

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