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PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study

Primary Purpose

Aortoiliac Aneurysms, Iliac Aneurysms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zenith® Branch Endovascular Graft-Iliac Bifurcation,
Atrium iCAST™
Zenith® Flex AAA Endovascular Graft
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment 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 aortioiliac or iliac aneurysm
  • An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac 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
  • Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
  • Unwilling or unable to comply with the follow-up schedule
  • Simultaneously participating in another investigative device or drug study

Sites / Locations

  • Mayo Foundation for Medical Education and Research
  • VA Palo Alto HCS
  • Stanford University Medical School
  • Christine E. Lynn Heart and Vascular Institute
  • South Florida Medical Imaging
  • University of Florida
  • Emory University Hospital
  • 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
  • University of Nebraska
  • Dartmouth Hitchcock Medical Center
  • Columbia University Medical Center
  • Weill Cornell Medical Center
  • University of North Carolina
  • Cleveland Clinic Foundation
  • 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zenith® Branch Endovascular Graft-Iliac Bifurcation

Arm Description

Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft

Outcomes

Primary Outcome Measures

Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms.

Secondary Outcome Measures

Freedom from morbidity (i.e., morbidity index)
Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).

Full Information

First Posted
September 28, 2015
Last Updated
June 24, 2021
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02571907
Brief Title
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
Official Title
Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 4, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a 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

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

8. Arms, Groups, and Interventions

Arm Title
Zenith® Branch Endovascular Graft-Iliac Bifurcation
Arm Type
Experimental
Arm Description
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Intervention Type
Device
Intervention Name(s)
Zenith® Branch Endovascular Graft-Iliac Bifurcation,
Other Intervention Name(s)
Branch Graft
Intervention Description
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Intervention Type
Device
Intervention Name(s)
Atrium iCAST™
Intervention Description
Implantation of Atrium iCAST
Intervention Type
Device
Intervention Name(s)
Zenith® Flex AAA Endovascular Graft
Intervention Description
Implantation of the Zenith Flex Endovascular Graft
Primary Outcome Measure Information:
Title
Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Freedom from morbidity (i.e., morbidity index)
Description
Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An aortioiliac or iliac aneurysm An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac 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 Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study Unwilling or unable to comply with the follow-up schedule Simultaneously participating in another investigative device or drug study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Anthony Lee, MD FACS
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 School
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 Hospital
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
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
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
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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 Clinical Study

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