AneuRx Post Market Study in the Treatment of AAA

October 27, 2021 updated by: Medtronic Cardiovascular

AneuRx Post Market Surveillance Registry

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States
    • Michigan
      • Royal Oak, Michigan, United States
    • New Jersey
      • Morristown, New Jersey, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Chapel Hill, North Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Collaborators

Medtronic

Investigators

  • Study Chair: Medtronic Cardiovascular, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS01000010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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