Clinical trial NCT00739401: Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
Official title: Endologix Powerlink® Suprarenal Proximal Cuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: AAA
Aneurysm
Suprarenal
Proximal
Cuff
Extension
Endograft
Endovascular repair
EVAR
Endoleak
Type I
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Subjects With Proximal Type I Endoleak
timeFrame: Within 30 Days
Secondary outcomes:
measure: Number of Subjects With Major Adverse Events
timeFrame: Within 30 days
measure: Number of Participants With Stent Graft Integrity and Performance
timeFrame: 30 days
measure: Endoleak
timeFrame: 30 days
measure: Aneurysm Morphology Changes
timeFrame: 30 days
measure: Renal Function
timeFrame: 30 days
measure: Aneurysm Morphology Changes
timeFrame: 30 days
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital - Pensacola Research Consultants
state: Florida
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Evansville
country: United States
facility: Deaconess Hospital - The Heart Group
state: Indiana
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University - Brody School of Medicine
state: North Carolina
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Robert Beasley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Carolina University Brody School of Medicine
name: William M. Bogey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Munroe Regional Medical Center
name: Robert Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sacred Heart Hospital - Pensacola Research
name: Stuart Harlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Jeffrey Lawson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lexington Medical Center
name: William Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orlando Regional Medical Center
name: Charles Thompson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deaconess Hospital - The Heart Group
name: Thomas E. Topper, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.