Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

Study Overview
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Brief Summary
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The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.

Official Title
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Endologix Powerlink® Suprarenal Proximal Cuff

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Suprarenal Proximal Cuff Extension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. | Device: Suprarenal Proximal Cuff Extension<br>* Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Endoleak | Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak. Endoleak diagnosis results as reported by the Core Lab. | 30 days | 
| Aneurysm Morphology Changes | Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab. | 30 days | 
| Renal Function | Renal function as measured by serum creatinine. Laboratory results, | 30 days | 
| Aneurysm Morphology Changes | Aneurysm morphology changes (Volume) as reported by CoreLab. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAA, Aneurysm, Suprarenal, Proximal, Cuff, Extension, Endograft, Endovascular repair, EVAR, Endoleak, Type I