PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
1 other identifier
interventional
40
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2020
CompletedResults Posted
Study results publicly available
July 16, 2025
CompletedJuly 16, 2025
June 1, 2025
1.6 years
September 28, 2015
June 27, 2025
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Freedom From Morbidity (i.e., Morbidity Index)
30 days
Study Arms (1)
Zenith® Branch Endovascular Graft-Iliac Bifurcation
EXPERIMENTALZenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Interventions
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Implantation of the Zenith Flex Endovascular Graft
Eligibility Criteria
You may qualify if:
- An aortioiliac or iliac aneurysm
- An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Mayo Foundation for Medical Education and Research
Phoenix, Arizona, 85054, United States
VA Palo Alto HCS
Palo Alto, California, 94304, United States
Stanford University Medical School
Stanford, California, 94305, United States
Christine E. Lynn Heart and Vascular Institute
Boca Raton, Florida, 33431, United States
South Florida Medical Imaging
Fort Lauderdale, Florida, 33308, United States
University of Florida
Gainesville, Florida, 32610, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
St. Anthony's Medical Center
Rockford, Illinois, 61108, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital East Communities
St Louis, Missouri, 63141, United States
University of Nebraska
Omaha, Nebraska, 68105, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern
Dallas, Texas, 75235, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Results Point of Contact
- Title
- Alan Saunders, MS, Senior Manager, Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
W. Anthony Lee, MD FACS
Christine E. Lynn Heart and Vascular Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 28, 2015
First Posted
October 8, 2015
Study Start
April 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 4, 2020
Last Updated
July 16, 2025
Results First Posted
July 16, 2025
Record last verified: 2025-06