Talent Aortic Cuff Stent Graft System Compassionate Use Registry

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00604643
First received: December 21, 2007
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysms
Device: TALENT Aortic Cuff Abdominal Stent Graft

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Study Start Date: October 2002
Estimated Study Completion Date: April 2012
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: TALENT Aortic Cuff Abdominal Stent Graft
    Endovascular Aneurysm Repair
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604643

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

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00604643     History of Changes
Other Study ID Numbers: Investigational Plan #025
Study First Received: December 21, 2007
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Abdominal Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft
Endograft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 17, 2014