Brief Title
AneuRx Post Market Study in the Treatment of AAA
Official Title
AneuRx Post Market Surveillance Registry
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.
Study Type
Interventional
Primary Outcome
Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
Secondary Outcome
Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Condition
Abdominal Aneurysm
Intervention
AneuRx Stent Graft
Study Arms / Comparison Groups
Lifeline Registry
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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
349
Start Date
July 2003
Completion Date
February 2009
Primary Completion Date
February 2008
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medtronic Cardiovascular, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00604552
Organization ID
PS01000010
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic
Study Sponsor
Medtronic Cardiovascular, Study Chair, Medtronic
Verification Date
October 2021