Clinical trial NCT00543270: Powerlink Bifurcated Stent Graft Long-Term Follow-up Study
Official title: Endologix Powerlink Long-Term Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: EVAR
AAA
Aneurysm
Powerlink
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endologix Infrarenal Bifurcated Stent Graft Study


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

Primary outcomes:
measure: No of Subjects with Major adverse events
timeFrame: At 1 Year
measure: All Cause Mortality
timeFrame: At 1 Year
Secondary outcomes:
measure: Stent Graft Performance
timeFrame: 30 Days
measure: Stent Graft Performance
timeFrame: 6 Months
measure: Stent Graft Performance
timeFrame: Year 1
measure: Stent Graft Performance
timeFrame: Year 2
measure: Stent Graft Performance
timeFrame: Year 3
measure: Stent Graft Performance
timeFrame: Year 4
measure: Stent Graft Performance
timeFrame: Year 5
measure: Clinical Utility Outcomes
timeFrame: During the Procedure
measure: Clinical Utility Outcomes
timeFrame: During the Procedure
measure: Clinical Utility Outcomes
timeFrame: up to 1 week
measure: Clinical Utility Outcomes
timeFrame: up to 1 week
measure: Aneurysm Morphology
timeFrame: 6 Months
measure: Aneurysm Morphology
timeFrame: Year 1
measure: Aneurysm Morphology
timeFrame: Year 2
measure: Aneurysm Morphology
timeFrame: Year 3
measure: Aneurysm Morphology
timeFrame: Year 4
measure: Aneurysm Morphology
timeFrame: Year 5
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Peoria
country: United States
facility: University of Illinois School of Medicine
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Des Moines
country: United States
facility: Mercy Hospital
state: Iowa
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Morristown
country: United States
facility: Advanced Vascular Associates
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Philadelphia
country: United States
facility: University Hospital of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Sioux Falls
country: United States
facility: Heart Hospital of South Dakota
state: South Dakota
city: Norfolk
country: United States
facility: Vascular and Transplant Specialists
state: Virginia
Study officials:
affiliation: University of California, Los Angeles
name: Rodney White, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carpenter JP. The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial. J Cardiovasc Surg (Torino). 2006 Jun;47(3):239-43.
citation: 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.
citation: Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. doi: 10.1177/1538574408327570. Epub 2008 Dec 16.
citation: Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535-45. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16.