Talent Aortic Cuff Stent Graft System Compassionate Use Registry

October 27, 2021 updated by: Medtronic Cardiovascular

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • Baptist Hospital
    • California
      • Oakland, California, United States, 94611
        • Kaiser
      • San Jose, California, United States, 95128
        • O'Connor Hospital
      • Union City, California, United States, 94587
        • Kaiser Hayward
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Penrose Healthcare
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital
    • Florida
      • Clearwater, Florida, United States, 33757
        • Morton Plant Hospital
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Gainesville, Florida, United States, 32605
        • North Florida Regional Medical Center
      • Ocala, Florida, United States, 34474
        • Munroe Regional Medical Center
      • Tampa, Florida, United States, 33612
        • JA Haley Veterans Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's Hospital
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Hospital
    • Illinois
      • La Grange, Illinois, United States, 60525
        • LaGrange Memorial Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Southwest Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Bon Secours Cottage Health Center
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Medical Center
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • St. Cloud Hospital
      • Saint Paul, Minnesota, United States, 55105
        • Health Easst St. Joseph's Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • CV Surgical Clinic
      • Jackson, Mississippi, United States, 39202
        • St. Dominic-Jackson
      • Meridian, Mississippi, United States, 39301
        • Jeff Anderson Regional Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • NMVA Healthcare
    • New York
      • Utica, New York, United States, 13502
        • St. Luke's Healthcare
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Charlotte, North Carolina, United States, 28203
        • The Sanger Clinic-Carolinas Medical
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Kaiser Sunnyside
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Pinnacle Health Hospital
      • Philadelphia, Pennsylvania, United States, 19102
        • Hahnemann Univeristy Hospital
      • Philadelphia, Pennsylvania, United States, 19146
        • Graduate Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Providence Hospital
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • North Central Heart Institute
    • Texas
      • Harlingen, Texas, United States, 78550
        • Harlingen Medical Center
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
      • Houston, Texas, United States, 77090
        • Houston Northwest Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05402
        • University of Vermont
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Henrico Doctors' Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Study Director: Medtronic CardioVascular, Medtronic Cardiovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 16, 2008

First Posted (ESTIMATE)

January 30, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Investigational Plan #025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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