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Talent Aortic Cuff Stent Graft System Compassionate Use Registry

Primary Purpose

Abdominal Aortic Aneurysms

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
TALENT Aortic Cuff Abdominal Stent Graft
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Abdominal Aortic Aneurysms focused on measuring Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Hospital
  • Kaiser
  • O'Connor Hospital
  • Kaiser Hayward
  • Penrose Healthcare
  • Hartford Hospital
  • Washington Hospital
  • Morton Plant Hospital
  • North Florida Regional Medical Center
  • University of Florida
  • Munroe Regional Medical Center
  • JA Haley Veterans Hospital
  • St. Joseph's Hospital
  • Gwinnett Hospital
  • LaGrange Memorial Hospital
  • Iowa Heart Center
  • Via Christi Regional Medical center
  • University of Kentucky medical Center
  • Baptist Hospital
  • Southwest Medical Center
  • Greater Baltimore Medical Center
  • University of Massachusetts
  • Bon Secours Cottage Health Center
  • Lakeland Regional Medical Center
  • St. Cloud Hospital
  • Health Easst St. Joseph's Hospital
  • CV Surgical Clinic
  • St. Dominic-Jackson
  • Jeff Anderson Regional Medical Center
  • St. Luke's
  • Washington University School of Medicine
  • St. John's Mercy Medical Center
  • Dartmouth-Hitchcock
  • NMVA Healthcare
  • St. Luke's Healthcare
  • Mission Hospital
  • The Sanger Clinic-Carolinas Medical
  • Kaiser Sunnyside
  • Pinnacle Health Hospital
  • Hahnemann Univeristy Hospital
  • Graduate Hospital
  • Providence Hospital
  • Lexington Medical Center
  • North Central heart Institute
  • Harlingen Medical Center
  • St. Luke's Episcopal Hospital
  • Houston Northwest Medical Center
  • University of Vermont
  • Henrico Doctors' Hospital
  • St. Luke's medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 21, 2007
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00604643
Brief Title
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
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
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
TALENT Aortic Cuff Abdominal Stent Graft
Intervention Description
Endovascular Aneurysm Repair

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medtronic CardioVascular
Organizational Affiliation
Medtronic Cardiovascular
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Hospital
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Kaiser
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
O'Connor Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Kaiser Hayward
City
Union City
State/Province
California
ZIP/Postal Code
94587
Country
United States
Facility Name
Penrose Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Washington Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33757
Country
United States
Facility Name
North Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
JA Haley Veterans Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gwinnett Hospital
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
LaGrange Memorial Hospital
City
La Grange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Via Christi Regional Medical center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Kentucky medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Baptist Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Southwest Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Bon Secours Cottage Health Center
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Health Easst St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55105
Country
United States
Facility Name
CV Surgical Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
St. Dominic-Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Jeff Anderson Regional Medical Center
City
Meridian
State/Province
Mississippi
ZIP/Postal Code
39301
Country
United States
Facility Name
St. Luke's
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dartmouth-Hitchcock
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
NMVA Healthcare
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
St. Luke's Healthcare
City
Utica
State/Province
New York
ZIP/Postal Code
13502
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
The Sanger Clinic-Carolinas Medical
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Kaiser Sunnyside
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Pinnacle Health Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Hahnemann Univeristy Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Graduate Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Providence Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
North Central heart Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Harlingen Medical Center
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Northwest Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05402
Country
United States
Facility Name
Henrico Doctors' Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
St. Luke's medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Talent Aortic Cuff Stent Graft System Compassionate Use Registry

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