Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
This trial is active, not recruiting.
|Condition||abdominal aortic aneurysm|
|Treatment||suprarenal proximal cuff extension|
|Start date||May 2006|
|End date||July 2008|
|Trial size||44 participants|
|Trial identifier||NCT00739401, CP04-002, IDE G990139|
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Miami Beach, FL||Mount Sinai Medical Center||no longer recruiting|
|Ocala, FL||Munroe Regional Medical Center||no longer recruiting|
|Orlando, FL||Orlando Regional Hospital||no longer recruiting|
|Pensacola, FL||Sacred Heart Hospital - Pensacola Research Consultants||no longer recruiting|
|Peoria, IL||Methodist Medical Center of Illinois||no longer recruiting|
|Evansville, IN||Deaconess Hospital - The Heart Group||no longer recruiting|
|Durham, NC||Duke University Hospital||no longer recruiting|
|Greenville, NC||East Carolina University - Brody School of Medicine||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Proximal type I endoleak
time frame: Within 30 Days
Major adverse events; delivery and deployment success, device integrity, patency, graft migration; and renal function.
time frame: Within 30 days
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Criteria: - 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
|Official title||Endologix Powerlink® Suprarenal Proximal Cuff|
|Principal investigator||Robert Beasley, MD|
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