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NCT00604643 Clinical Trial

Talent Aortic Cuff Stent Graft System Compassionate Use Registry

Abdominal Aortic Aneurysms Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00604643
Other study ID # Investigational Plan #025
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date October 2021
Source Medtronic Cardiovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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 information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States NMVA Healthcare Albuquerque New Mexico
United States Mission Hospital Asheville North Carolina
United States St. Joseph's Hospital Atlanta Georgia
United States Greater Baltimore Medical Center Baltimore Maryland
United States University of Vermont Burlington Vermont
United States The Sanger Clinic-Carolinas Medical Charlotte North Carolina
United States Kaiser Sunnyside Clackamas Oregon
United States Morton Plant Hospital Clearwater Florida
United States Penrose Healthcare Colorado Springs Colorado
United States Providence Hospital Columbia South Carolina
United States Iowa Heart Center Des Moines Iowa
United States North Florida Regional Medical Center Gainesville Florida
United States University of Florida Gainesville Florida
United States Harlingen Medical Center Harlingen Texas
United States Pinnacle Health Hospital Harrisburg Pennsylvania
United States Hartford Hospital Hartford Connecticut
United States Houston Northwest Medical Center Houston Texas
United States St. Luke's Episcopal Hospital Houston Texas
United States CV Surgical Clinic Jackson Mississippi
United States St. Dominic-Jackson Jackson Mississippi
United States St. Luke's Kansas City Missouri
United States LaGrange Memorial Hospital La Grange Illinois
United States Southwest Medical Center Lafayette Louisiana
United States Gwinnett Hospital Lawrenceville Georgia
United States Dartmouth-Hitchcock Lebanon New Hampshire
United States University of Kentucky medical Center Lexington Kentucky
United States Baptist Hospital Louisville Kentucky
United States Jeff Anderson Regional Medical Center Meridian Mississippi
United States St. Luke's medical Center Milwaukee Wisconsin
United States Baptist Hospital Montgomery Alabama
United States Kaiser Oakland California
United States Munroe Regional Medical Center Ocala Florida
United States Graduate Hospital Philadelphia Pennsylvania
United States Hahnemann Univeristy Hospital Philadelphia Pennsylvania
United States Henrico Doctors' Hospital Richmond Virginia
United States Bon Secours Cottage Health Center Saint Clair Shores Michigan
United States St. Cloud Hospital Saint Cloud Minnesota
United States Lakeland Regional Medical Center Saint Joseph Michigan
United States St. John's Mercy Medical Center Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Health Easst St. Joseph's Hospital Saint Paul Minnesota
United States O'Connor Hospital San Jose California
United States North Central heart Institute Sioux Falls South Dakota
United States JA Haley Veterans Hospital Tampa Florida
United States Kaiser Hayward Union City California
United States St. Luke's Healthcare Utica New York
United States Washington Hospital Washington District of Columbia
United States Lexington Medical Center West Columbia South Carolina
United States Via Christi Regional Medical center Wichita Kansas
United States University of Massachusetts Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

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