Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: Suprarenal Proximal Cuff Extension

• Registration Number: NCT00739401
• Lead Sponsor: Endologix

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-05
• Primary Completion: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-21
• Study Completion: 2009-08
• Disposition First Submitted: 2011-09-17
• Disposition First Submitted QC: 2011-09-29
• Disposition First Posted: 2011-10-05
• Results First Submitted: 2021-09-23
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-09
• Last Update Submitted: 2021-12-09
• Results First Posted: 2021-12-10
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Suprarenal Proximal Cuff Extension	Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Proximal Type I Endoleak	Within 30 Days	The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Orlando Regional Hospital; 🇺🇸 Orlando, Florida, United States

Munroe Regional Medical Center; 🇺🇸 Ocala, Florida, United States

Methodist Medical Center of Illinois; 🇺🇸 Peoria, Illinois, United States

East Carolina University - Brody School of Medicine; 🇺🇸 Greenville, North Carolina, United States

Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Sacred Heart Hospital - Pensacola Research Consultants; 🇺🇸 Pensacola, Florida, United States

Deaconess Hospital - The Heart Group; 🇺🇸 Evansville, Indiana, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States