AneuRx Post Market Study in the Treatment of AAA

Abdominal Aneurysm Clinical Trial

Official title:

AneuRx Post Market Surveillance Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00604552
• Other study ID #: PS01000010
• Status: Terminated
• Phase: N/A
• Start date: July 2003
• Est. completion date: February 2009

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 349
• Est. completion date: February 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aneurysm
• Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• AneuRx Stent Graft
Abdominal Aortic Aneurysm Repair

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events		5 years