AneuRx Post Market Study in the Treatment of AAA
Not Applicable
Terminated
- Conditions
- Abdominal Aneurysm
- Interventions
- Device: AneuRx Stent Graft
- Registration Number
- NCT00604552
- Lead Sponsor
- Medtronic Cardiovascular
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 349
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lifeline Registry AneuRx Stent Graft 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) PS Registry AneuRx Stent Graft All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
- Primary Outcome Measures
Name Time Method Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion 5 year Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
- Secondary Outcome Measures
Name Time Method Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events 5 years