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Zenith® Low Profile AAA Endovascular Graft

Primary Purpose

Abdominal Aortic Aneurysms, Iliac Aneurysms, Aortoiliac Aneurysms

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zenith Low Profile AAA Endovascular Graft and ancillary components
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring Low Profile, Abdominal Aortic Aneurysms, Endovascular

Eligibility Criteria

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

Inclusion Criteria:

  • Subject has at least one of the following

    • Aortic or aortoiliac aneurysm
    • Iliac aneurysm
    • Aneurysm with a history of growth

Exclusion Criteria:

  • Less than 18 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Pregnant of breastfeeding or planning on becoming pregnant with 60 months
  • Unwilling to comply with the follow-up schedule

Sites / Locations

  • Stanford University Medical Center
  • University of Colorado
  • Hartford Hospital
  • Washington Hospital Center
  • Morton Plant Hospital
  • University of Florida
  • Piedmont Hospital
  • Iowa Heart Center
  • Baptist Health Louisville
  • Massachusetts General
  • University of Massachusetts Medical School
  • Borgess Research Institute
  • Wm Beaumont Hospital
  • Mayo Clinic Rochester
  • Missouri Heart Center
  • St. John's Mercy Medical Center
  • St. Vincent's Heart and Vascular Center
  • Cooper University Hospital
  • Newark Beth Israel Medical Center
  • New York University - Langone Medical Center
  • University of Rochester
  • SUNY at Stony Brook Hospital
  • SUNY Upstate
  • Wake Forest Baptist Medical Center
  • Summa Akron
  • Good Samaritan-Trihealth
  • Bend Memorial Clinic
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Baptist Memorial Hospital-Memphis
  • Sentara Vascular Specialists
  • University of Washington-Harborview Medical Center
  • Charleston Area Medical Center
  • Gundersen Lutheran Medical Center
  • Aspirus Wausau
  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Graft

Arm Description

The Zenith Low Profile AAA Endovascular Graft and ancillary components

Outcomes

Primary Outcome Measures

Number of Patients Without Major Adverse Events Within 30 Days
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Number of Patients With Device Success
Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm

Secondary Outcome Measures

Full Information

First Posted
August 26, 2015
Last Updated
March 23, 2022
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02535065
Brief Title
Zenith® Low Profile AAA Endovascular Graft
Official Title
Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

5. Study Description

Brief Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms, Iliac Aneurysms, Aortoiliac Aneurysms
Keywords
Low Profile, Abdominal Aortic Aneurysms, Endovascular

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Endovascular Graft
Arm Type
Experimental
Arm Description
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Intervention Type
Device
Intervention Name(s)
Zenith Low Profile AAA Endovascular Graft and ancillary components
Intervention Description
Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
Primary Outcome Measure Information:
Title
Number of Patients Without Major Adverse Events Within 30 Days
Description
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Time Frame
30 days
Title
Number of Patients With Device Success
Description
Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has at least one of the following Aortic or aortoiliac aneurysm Iliac aneurysm Aneurysm with a history of growth Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Pregnant of breastfeeding or planning on becoming pregnant with 60 months Unwilling to comply with the follow-up schedule
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Baptist Health Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Massachusetts General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Wm Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Missouri Heart Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. Vincent's Heart and Vascular Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
New York University - Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY at Stony Brook Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
25157
Country
United States
Facility Name
Summa Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States
Facility Name
Good Samaritan-Trihealth
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Baptist Memorial Hospital-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Washington-Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Aspirus Wausau
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Zenith® Low Profile AAA Endovascular Graft

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