AneuRx Post Market Study in the Treatment of AAA

This study has been terminated.
(Mutual agreement between FDA closed the 522 postmarket surveillance Registry.)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00604552
First received: December 21, 2007
Last updated: June 24, 2013
Last verified: January 2013
  Purpose

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 Intervention
Abdominal Aneurysm
Device: AneuRx Stent Graft

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AneuRx Post Market Surveillance Registry

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

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


Secondary Outcome Measures:
  • Evaluate the Occurrence of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 349
Study Start Date: July 2003
Study Completion Date: February 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00604552     History of Changes
Other Study ID Numbers: PS01000010
Study First Received: December 21, 2007
Results First Received: February 21, 2013
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014