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Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suprarenal Proximal Cuff Extension
Sponsored by
Endologix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring AAA, Aneurysm, Suprarenal, Proximal, Cuff, Extension, Endograft, Endovascular repair, EVAR, Endoleak, Type I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Medical Center
  • Munroe Regional Medical Center
  • Orlando Regional Hospital
  • Sacred Heart Hospital - Pensacola Research Consultants
  • Methodist Medical Center of Illinois
  • Deaconess Hospital - The Heart Group
  • Duke University Hospital
  • East Carolina University - Brody School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2008
Last Updated
December 9, 2021
Sponsor
Endologix
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1. Study Identification

Unique Protocol Identification Number
NCT00739401
Brief Title
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
Official Title
Endologix Powerlink® Suprarenal Proximal Cuff
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2006 (Actual)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
AAA, Aneurysm, Suprarenal, Proximal, Cuff, Extension, Endograft, Endovascular repair, EVAR, Endoleak, Type I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.
Intervention Type
Device
Intervention Name(s)
Suprarenal Proximal Cuff Extension
Intervention Description
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft
Primary Outcome Measure Information:
Title
Number of Subjects With Proximal Type I Endoleak
Description
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 Outcome Measure Information:
Title
Number of Subjects With Major Adverse Events
Description
All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke
Time Frame
Within 30 days
Title
Number of Participants With Stent Graft Integrity and Performance
Description
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
Title
Endoleak
Description
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
Title
Aneurysm Morphology Changes
Description
Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.
Time Frame
30 days
Title
Renal Function
Description
Renal function as measured by serum creatinine. Laboratory results,
Time Frame
30 days
Title
Aneurysm Morphology Changes
Description
Aneurysm morphology changes (Volume) as reported by CoreLab.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Beasley, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William M. Bogey, MD
Organizational Affiliation
East Carolina University Brody School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Feldman, MD
Organizational Affiliation
Munroe Regional Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Harlin, MD
Organizational Affiliation
Sacred Heart Hospital - Pensacola Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Lawson, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Moore, MD
Organizational Affiliation
Lexington Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Thompson, MD
Organizational Affiliation
Orlando Regional Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas E. Topper, MD
Organizational Affiliation
Deaconess Hospital - The Heart Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Orlando Regional Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Hospital - Pensacola Research Consultants
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Deaconess Hospital - The Heart Group
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University - Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16414382
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. doi: 10.1016/j.jvs.2005.09.025.
Results Reference
background
PubMed Identifier
20831993
Citation
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;24(7):921-9. doi: 10.1016/j.avsg.2010.05.008.
Results Reference
result
Links:
URL
http://www.endologix.com
Description
Sponsor Information

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Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

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