Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

December 9, 2021 updated by: Endologix

Endologix Powerlink® Suprarenal Proximal Cuff

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 Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Ocala, Florida, United States, 34474
        • Munroe Regional Medical Center
      • Orlando, Florida, United States, 32806
        • Orlando Regional Hospital
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital - Pensacola Research Consultants
    • Illinois
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Deaconess Hospital - The Heart Group
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
      • Greenville, North Carolina, United States, 27834
        • East Carolina University - Brody School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Proximal Type I Endoleak
Time Frame: Within 30 Days
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
Time Frame: Within 30 days
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
Time Frame: 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
30 days
Endoleak
Time Frame: 30 days

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
Time Frame: 30 days
Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.
30 days
Renal Function
Time Frame: 30 days
Renal function as measured by serum creatinine. Laboratory results,
30 days
Aneurysm Morphology Changes
Time Frame: 30 days
Aneurysm morphology changes (Volume) as reported by CoreLab.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2006

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (ESTIMATE)

August 21, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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