PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation
Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
1 other identifier
expanded_access
N/A
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedDecember 16, 2020
December 1, 2020
June 15, 2015
December 14, 2020
Conditions
Keywords
Interventions
Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.
Eligibility Criteria
You may qualify if:
- An aortoiliac or iliac aneurysm of appropriate size
- Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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
- Unsuitable arterial anatomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
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 Center
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
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
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
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
Study Officials
- PRINCIPAL INVESTIGATOR
W. Anthony Lee, MD
Christine E. Lynn Heart and Vascular Institute
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2015
First Posted
June 19, 2015
Last Updated
December 16, 2020
Record last verified: 2020-12