Back to resultsAneuRx Post Market Study in the Treatment of AAA
Primary Purpose
Abdominal Aneurysm
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AneuRx Stent Graft
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aneurysm focused on measuring Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
Eligibility Criteria
Inclusion Criteria:
- Patients implanted with an AneuRx Stent Graft per Instructions for Use
- Patients must provide written informed consent and agree to be accessible for follow-up at the study center.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lifeline Registry
PS Registry
Arm Description
All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
Outcomes
Primary Outcome Measures
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
Secondary Outcome Measures
Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Full Information
NCT ID
NCT00604552
First Posted
December 21, 2007
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00604552
Brief Title
AneuRx Post Market Study in the Treatment of AAA
Official Title
AneuRx Post Market Surveillance Registry
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Mutual agreement between FDA closed the 522 postmarket surveillance Registry.
Study Start Date
July 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair.
The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aneurysm
Keywords
Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
349 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifeline Registry
Arm Type
Other
Arm Description
All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
Arm Title
PS Registry
Arm Type
Other
Arm Description
All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
Intervention Type
Device
Intervention Name(s)
AneuRx Stent Graft
Intervention Description
Abdominal Aortic Aneurysm Repair
Primary Outcome Measure Information:
Title
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
Description
Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients implanted with an AneuRx Stent Graft per Instructions for Use
Patients must provide written informed consent and agree to be accessible for follow-up at the study center.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medtronic Cardiovascular
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Morristown
State/Province
New Jersey
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Sioux Falls
State/Province
South Dakota
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
AneuRx Post Market Study in the Treatment of AAA
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