Status:
COMPLETED
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
Lead Sponsor:
Endologix
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
Eligibility Criteria
Inclusion
- 18 years old
- Informed consent understood and signed
- Will comply with post-treatment follow-up requirements up to 5 years
- Candidate for Powerlink Infrarenal Bifurcated Graft
Exclusion
- Life expectancy \< 2 years
- Participating in another clinical research study
- Pregnant or lactating women
- Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study
- Creatinine level \> 1.7mg/dl
- Renal transplant patient
- Patient with \> 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation
Key Trial Info
Start Date :
May 5 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00739401
Start Date
May 5 2006
End Date
August 1 2009
Last Update
December 10 2021
Active Locations (8)
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1
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
2
Munroe Regional Medical Center
Ocala, Florida, United States, 34474
3
Orlando Regional Hospital
Orlando, Florida, United States, 32806
4
Sacred Heart Hospital - Pensacola Research Consultants
Pensacola, Florida, United States, 32504