Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
Endologix Powerlink® Suprarenal Proximal Cuff
2 other identifiers
interventional
44
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 21, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
December 10, 2021
CompletedDecember 10, 2021
December 1, 2021
2.2 years
August 19, 2008
September 23, 2021
December 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Proximal Type I Endoleak
The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.
Within 30 Days
Secondary Outcomes (6)
Number of Subjects With Major Adverse Events
Within 30 days
Number of Participants With Stent Graft Integrity and Performance
30 days
Endoleak
30 days
Aneurysm Morphology Changes
30 days
Renal Function
30 days
- +1 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALTest subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
Interventions
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endologixlead
Study Sites (8)
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Munroe Regional Medical Center
Ocala, Florida, 34474, United States
Orlando Regional Hospital
Orlando, Florida, 32806, United States
Sacred Heart Hospital - Pensacola Research Consultants
Pensacola, Florida, 32504, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Deaconess Hospital - The Heart Group
Evansville, Indiana, 47710, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
East Carolina University - Brody School of Medicine
Greenville, North Carolina, 27834, United States
Related Publications (2)
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.
PMID: 16414382BACKGROUNDHarlin 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.
PMID: 20831993RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elisa Hebb, VP Clinical Affairs
- Organization
- Endologix
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Beasley, MD
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
William M. Bogey, MD
East Carolina University Brody School of Medicine
- PRINCIPAL INVESTIGATOR
Robert Feldman, MD
Munroe Regional Medical Center
- PRINCIPAL INVESTIGATOR
Stuart Harlin, MD
Sacred Heart Hospital - Pensacola Research
- PRINCIPAL INVESTIGATOR
Jeffrey Lawson, MD
Duke University
- PRINCIPAL INVESTIGATOR
William Moore, MD
Lexington Medical Center
- PRINCIPAL INVESTIGATOR
Charles Thompson, MD
Orlando Regional Medical Center
- PRINCIPAL INVESTIGATOR
Thomas E. Topper, MD
Deaconess Hospital - The Heart Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 21, 2008
Study Start
May 5, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2009
Last Updated
December 10, 2021
Results First Posted
December 10, 2021
Record last verified: 2021-12