AneuRx Post Market Study in the Treatment of AAA

NCT00604552 | Terminated Results

• 1 other identifier: PS01000010
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 8

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.

Conditions

Abdominal Aneurysm

Keywords

Abdominal Aneurysm; Endovascular Aortic Repair (EVAR); Endovascular Stent Graft; Endograft

Outcome Measures

Primary Outcomes (1)

• Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion

  Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion

  5 year

Secondary Outcomes (1)

• Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events

  5 years

Study Arms (2)

Lifeline Registry

OTHER

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

PS Registry

OTHER

All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic

Device: AneuRx Stent Graft

Interventions

AneuRx Stent Graft DEVICE

Abdominal Aortic Aneurysm Repair

Lifeline Registry; PS Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead
• Medtronic: collaborator

Study Sites (8)

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Royal Oak, Michigan, United States

Location

Unknown Facility

Morristown, New Jersey, United States

Location

Unknown Facility

Asheville, North Carolina, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Sioux Falls, South Dakota, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Angela Parsons
• Organization: Medtronic Vascular

angela.r.parsons@medtronic.com

707-591-2293

Study Officials

• Medtronic Cardiovascular

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 30, 2008
• Study Start: July 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2009
• Last Updated: October 29, 2021
• Results First Posted: July 30, 2013

Record last verified: 2021-10

Locations

US (8)