Talent Aortic Cuff Stent Graft System Compassionate Use Registry

NCT ID: NCT00604643

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Abdominal Aortic Aneurysms

Keywords

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Abdominal Aneurysm Endovascular Aortic Repair (EVAR) Endovascular Stent Graft Endograft

Interventions

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TALENT Aortic Cuff Abdominal Stent Graft

Endovascular Aneurysm Repair

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medtronic CardioVascular

Role: STUDY_DIRECTOR

Medtronic Cardiovascular

Locations

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Baptist Hospital

Montgomery, Alabama, United States

Site Status

Kaiser

Oakland, California, United States

Site Status

O'Connor Hospital

San Jose, California, United States

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Kaiser Hayward

Union City, California, United States

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Penrose Healthcare

Colorado Springs, Colorado, United States

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Hartford Hospital

Hartford, Connecticut, United States

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Washington Hospital

Washington D.C., District of Columbia, United States

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Morton Plant Hospital

Clearwater, Florida, United States

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North Florida Regional Medical Center

Gainesville, Florida, United States

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University of Florida

Gainesville, Florida, United States

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Munroe Regional Medical Center

Ocala, Florida, United States

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JA Haley Veterans Hospital

Tampa, Florida, United States

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St. Joseph's Hospital

Atlanta, Georgia, United States

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Gwinnett Hospital

Lawrenceville, Georgia, United States

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LaGrange Memorial Hospital

La Grange, Illinois, United States

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Iowa Heart Center

Des Moines, Iowa, United States

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Via Christi Regional Medical center

Wichita, Kansas, United States

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University of Kentucky medical Center

Lexington, Kentucky, United States

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Baptist Hospital

Louisville, Kentucky, United States

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Southwest Medical Center

Lafayette, Louisiana, United States

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Greater Baltimore Medical Center

Baltimore, Maryland, United States

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University of Massachusetts

Worcester, Massachusetts, United States

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Bon Secours Cottage Health Center

Saint Clair Shores, Michigan, United States

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Lakeland Regional Medical Center

Saint Joseph, Michigan, United States

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St. Cloud Hospital

Saint Cloud, Minnesota, United States

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Health Easst St. Joseph's Hospital

Saint Paul, Minnesota, United States

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CV Surgical Clinic

Jackson, Mississippi, United States

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St. Dominic-Jackson

Jackson, Mississippi, United States

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Jeff Anderson Regional Medical Center

Meridian, Mississippi, United States

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St. Luke's

Kansas City, Missouri, United States

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Washington University School of Medicine

St Louis, Missouri, United States

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St. John's Mercy Medical Center

St Louis, Missouri, United States

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Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

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NMVA Healthcare

Albuquerque, New Mexico, United States

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St. Luke's Healthcare

Utica, New York, United States

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Mission Hospital

Asheville, North Carolina, United States

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The Sanger Clinic-Carolinas Medical

Charlotte, North Carolina, United States

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Kaiser Sunnyside

Clackamas, Oregon, United States

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Pinnacle Health Hospital

Harrisburg, Pennsylvania, United States

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Hahnemann Univeristy Hospital

Philadelphia, Pennsylvania, United States

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Graduate Hospital

Philadelphia, Pennsylvania, United States

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Providence Hospital

Columbia, South Carolina, United States

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Lexington Medical Center

West Columbia, South Carolina, United States

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North Central heart Institute

Sioux Falls, South Dakota, United States

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Harlingen Medical Center

Harlingen, Texas, United States

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St. Luke's Episcopal Hospital

Houston, Texas, United States

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Houston Northwest Medical Center

Houston, Texas, United States

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University of Vermont

Burlington, Vermont, United States

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Henrico Doctors' Hospital

Richmond, Virginia, United States

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St. Luke's medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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Investigational Plan #025

Identifier Type: -

Identifier Source: org_study_id