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NCT00739401 Clinical Trial

Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Endologix Powerlink® Suprarenal Proximal Cuff

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00739401
Other study ID # CP04-002
Secondary ID IDE G990139
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2006
Est. completion date August 2009

Study information
Verified date December 2021
Source Endologix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date August 2009
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Suprarenal Proximal Cuff Extension
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft

Locations
Country Name City State
United States Duke University Hospital Durham North Carolina
United States Deaconess Hospital - The Heart Group Evansville Indiana
United States East Carolina University - Brody School of Medicine Greenville North Carolina
United States Mount Sinai Medical Center Miami Beach Florida
United States Munroe Regional Medical Center Ocala Florida
United States Orlando Regional Hospital Orlando Florida
United States Sacred Heart Hospital - Pensacola Research Consultants Pensacola Florida
United States Methodist Medical Center of Illinois Peoria Illinois

Sponsors (1)
Lead Sponsor Collaborator
Endologix

Country where clinical trial is conducted

United States, 

References & Publications (2)

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; — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of Subjects With Major Adverse Events All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke Within 30 days
Secondary Number of Participants With Stent Graft Integrity and Performance Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results 30 days
Secondary Endoleak Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak.
Endoleak diagnosis results as reported by the Core Lab.		 30 days
Secondary Aneurysm Morphology Changes Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab. 30 days
Secondary Renal Function Renal function as measured by serum creatinine. Laboratory results, 30 days
Secondary Aneurysm Morphology Changes Aneurysm morphology changes (Volume) as reported by CoreLab. 30 days
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