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Zenith® Low Profile AAA Endovascular Graft

Primary Purpose

Abdominal Aortic Aneurysms, Iliac Aneurysms, Aorto-iliac Aneurysms

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Zenith Low Profile AAA Endovascular Graft
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access 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
  • Life expectancy less than 2 years
  • Pregnant of breastfeeding or planning on becoming pregnant with 60 months
  • Unwilling to comply with the follow-up schedule

Sites / Locations

  • University of California San Francisco-VA
  • University of California, San Francisco
  • Stanford University Medical School
  • Yale New Haven School of Medicine
  • University of Florida
  • Massachusetss General Hospital
  • University of Michigan Health System
  • William Beaumont Hospital
  • Mayo Clinic
  • Barnes-Jewish Hospital
  • Mercy Hospital
  • Morristown Memorial Hospital
  • New York University - Langone Medical Center
  • New York Presbyterian Hospital - Cornell
  • New York Presbyterian - Columbia
  • University of North Carolina
  • Cleveland Clinic
  • Ohio Health Research Institute
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • University of Washington-Harborview Medical Center
  • Aurora Saint Luke's Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 22, 2015
Last Updated
March 8, 2018
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02557659
Brief Title
Zenith® Low Profile AAA Endovascular Graft
Official Title
Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
Study Type
Expanded Access

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.

6. Conditions and Keywords

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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Zenith Low Profile AAA Endovascular Graft
Intervention Description
Treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair

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 Life expectancy less than 2 years Pregnant of breastfeeding or planning on becoming pregnant with 60 months Unwilling to comply with the follow-up schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Fairman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco-VA
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-001
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical School
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale New Haven School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Massachusetss General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6095
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
New York Presbyterian Hospital - Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Presbyterian - Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10065-4870
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
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 Washington-Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Zenith® Low Profile AAA Endovascular Graft

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