AneuRx Post Market Study in the Treatment of AAA
Not Applicable
Terminated
- Conditions
- Abdominal Aneurysm
- 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
- 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