Expired Study
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Sioux Falls, South Dakota


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.


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.


Study is Available At:


Original ID:

PS01000010


NCT ID:

NCT00604552


Secondary ID:


Study Acronym:


Brief Title:

AneuRx Post Market Study in the Treatment of AAA


Official Title:

AneuRx Post Market Surveillance Registry


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medtronic Endovascular


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Mutual agreement between FDA closed the 522


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

349


Enrollment Type:

Actual


Overall Contact Information

Official Name:Medtronic Cardiovascular
Study Chair
Medtronic

Study Dates

Start Date:July 2003
Completion Date:February 2009
Completion Type:Actual
Primary Completion Date:February 2008
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:February 12, 2018
First Received Date:December 21, 2007
First Results Date:February 21, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
Time Frame:5 year
Safety Issues:False
Description:Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
Outcome Type:Secondary Outcome
Measure:Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Time Frame:5 years
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:AneuRx Stent Graft
Description:Abdominal Aortic Aneurysm Repair
Arm Name:Lifeline Registry

Study Arms

Study Arm Type:Other
Arm Name:PS Registry
Description:All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
Study Arm Type:Other
Arm Name: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)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Medtronic Endovascular
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Medtronic

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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