Brief Title
Powerlink Bifurcated Stent Graft Long-Term Follow-up Study
Official Title
Endologix Powerlink Long-Term Follow-up Study
Brief Summary
Powerlink Bifurcated Infrarenal long-term follow-up study
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Safety: Major adverse events. Effectiveness: Stent graft patency, aneurysm exclusion, aneurysm related mortality, and all-cause mortality.
Condition
Abdominal Aortic Aneurysm
Intervention
Powerlink infrarenal bifurcated stent graft delivery system
Study Arms / Comparison Groups
A
Description: EVAR (Powerlink System)
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
231
Start Date
October 2005
Completion Date
November 2009
Primary Completion Date
November 2009
Eligibility Criteria
Inclusion Criteria: - All surviving patients from the original study cohort who received the Powerlink device - All surviving patients from the original study cohort who were assigned to the open surgical control arm
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rodney White, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00543270
Organization ID
TP00-005/CP04-001
Study Sponsor
Endologix
Study Sponsor
Rodney White, MD, Principal Investigator, University of California, Los Angeles
Verification Date
February 2010