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AneuRx Post Market Study in the Treatment of AAA

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ClinicalTrials.gov Identifier: NCT00604552
Recruitment Status : Terminated (Mutual agreement between FDA closed the 522 postmarket surveillance Registry.)
First Posted : January 30, 2008
Results First Posted : July 30, 2013
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular

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.


Condition or disease Intervention/treatment Phase
Abdominal Aneurysm Device: AneuRx Stent Graft Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AneuRx Post Market Surveillance Registry
Study Start Date : July 2003
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Arm Intervention/treatment
Lifeline Registry
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)
Device: AneuRx Stent Graft
Abdominal Aortic Aneurysm Repair
PS Registry
All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
Device: AneuRx Stent Graft
Abdominal Aortic Aneurysm Repair



Primary Outcome Measures :
  1. Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion [ Time Frame: 5 year ]
    Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion


Secondary Outcome Measures :
  1. Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604552


Locations
United States, Arizona
Tucson, Arizona, United States
United States, Michigan
Royal Oak, Michigan, United States
United States, New Jersey
Morristown, New Jersey, United States
United States, North Carolina
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Medtronic Endovascular
Medtronic
Investigators
Study Chair: Medtronic Cardiovascular Medtronic

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00604552     History of Changes
Other Study ID Numbers: PS01000010
First Posted: January 30, 2008    Key Record Dates
Results First Posted: July 30, 2013
Last Update Posted: March 12, 2018
Last Verified: January 2013

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

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