Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

Endologix44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Aortic Aneurysm

Interventions

Suprarenal Proximal Cuff ExtensionDEVICE

Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

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.

Time frame: Within 30 Days

Secondary Outcomes

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

Time frame: 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

Time frame: 30 days

Endoleak

Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak. Endoleak diagnosis results as reported by the Core Lab.

Time frame: 30 days

Aneurysm Morphology Changes

Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.

Time frame: 30 days

Renal Function

Renal function as measured by serum creatinine. Laboratory results,

Time frame: 30 days

Aneurysm Morphology Changes

Aneurysm morphology changes (Volume) as reported by CoreLab.

Time frame: 30 days

Data from ClinicalTrials.gov

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