Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
NCT ID: NCT00739401
Last Updated: 2021-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2006-05-05
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
Suprarenal Proximal Cuff Extension
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Interventions
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Suprarenal Proximal Cuff Extension
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Endologix
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Beasley, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
William M. Bogey, MD
Role: PRINCIPAL_INVESTIGATOR
East Carolina University Brody School of Medicine
Robert Feldman, MD
Role: PRINCIPAL_INVESTIGATOR
Munroe Regional Medical Center
Stuart Harlin, MD
Role: PRINCIPAL_INVESTIGATOR
Sacred Heart Hospital - Pensacola Research
Jeffrey Lawson, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
William Moore, MD
Role: PRINCIPAL_INVESTIGATOR
Lexington Medical Center
Charles Thompson, MD
Role: PRINCIPAL_INVESTIGATOR
Orlando Regional Medical Center
Thomas E. Topper, MD
Role: PRINCIPAL_INVESTIGATOR
Deaconess Hospital - The Heart Group
Locations
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Mount Sinai Medical Center
Miami Beach, Florida, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Orlando Regional Hospital
Orlando, Florida, United States
Sacred Heart Hospital - Pensacola Research Consultants
Pensacola, Florida, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Deaconess Hospital - The Heart Group
Evansville, Indiana, United States
Duke University Hospital
Durham, North Carolina, United States
East Carolina University - Brody School of Medicine
Greenville, North Carolina, United States
Countries
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References
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Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025.
Harlin SA, Beasley RE, Feldman RL, Thompson CS, Williams JB. Endovascular abdominal aortic aneurysm repair using an anatomical fixation technique and concomitant suprarenal orientation: results of a prospective, multicenter trial. Ann Vasc Surg. 2010 Oct;24(7):921-9. doi: 10.1016/j.avsg.2010.05.008.
Related Links
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Sponsor Information
Other Identifiers
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IDE G990139
Identifier Type: OTHER
Identifier Source: secondary_id
CP04-002
Identifier Type: -
Identifier Source: org_study_id