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PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

Primary Purpose

Aortoiliac Aneurysms, Iliac Aneurysms

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Zenith® Branch Endovascular Graft-Iliac Bifurcation,
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Aortoiliac Aneurysms focused on measuring Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases

Eligibility Criteria

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

Inclusion Criteria:

  • An aortoiliac or iliac aneurysm of appropriate size
  • Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

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
  • Unsuitable arterial anatomy

Sites / Locations

  • Mayo Foundation for Medical Education and Research
  • VA Palo Alto HCS
  • Stanford University Medical Center
  • Christine E. Lynn Heart and Vascular Institute
  • South Florida Medical Imaging
  • University of Florida
  • Emory University
  • St. Anthony's Medical Center
  • Methodist Hospital of Indiana
  • University of Kentucky Hospital
  • University of Massachusetts
  • William Beaumont Hospital
  • Mayo Clinic
  • Washington University School of Medicine
  • Mercy Hospital East Communities
  • Dartmouth-Hitchcock Medical Center
  • Columbia University Medical Center
  • Weill Cornell Medical Center
  • University of North Carolina
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • UT Southwestern
  • University of Virginia
  • Aurora St. Luke's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 15, 2015
Last Updated
December 14, 2020
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02475798
Brief Title
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation
Official Title
Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
Study Type
Expanded Access

2. Study Status

Record Verification Date
December 2020
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 Research Incorporated

4. Oversight

5. Study Description

Brief Summary
The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortoiliac Aneurysms, Iliac Aneurysms
Keywords
Zenith aortoiliac aneurysm, Iliac aneurysm, Branch, Connections, Endovascular graft, Graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Zenith® Branch Endovascular Graft-Iliac Bifurcation,
Other Intervention Name(s)
Branch Graft
Intervention Description
Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An aortoiliac or iliac aneurysm of appropriate size Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery 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 Unsuitable arterial anatomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Anthony Lee, MD
Organizational Affiliation
Christine E. Lynn Heart and Vascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Foundation for Medical Education and Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
VA Palo Alto HCS
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Christine E. Lynn Heart and Vascular Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
South Florida Medical Imaging
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Anthony's Medical Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
Methodist Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital East Communities
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
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
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
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Aurora St. Luke's Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

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