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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiovascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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