Brief Title
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
Official Title
Endologix Powerlink® Suprarenal Proximal Cuff
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.
Study Type
Interventional
Primary Outcome
Number of Subjects With Proximal Type I Endoleak
Secondary Outcome
Number of Subjects With Major Adverse Events
Condition
Abdominal Aortic Aneurysm
Intervention
Suprarenal Proximal Cuff Extension
Study Arms / Comparison Groups
1
Description: Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
44
Start Date
May 5, 2006
Completion Date
August 2009
Primary Completion Date
August 2008
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert Beasley, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00739401
Organization ID
CP04-002
Secondary IDs
IDE G990139
Responsible Party
Sponsor
Study Sponsor
Endologix
Study Sponsor
Robert Beasley, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai
Verification Date
December 2021