PRESERVE-Zenith® Iliac Branch System Clinical Extended Study
Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation With the ConnectSX™
1 other identifier
expanded_access
N/A
1 country
19
Brief Summary
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2012
Longer than P75 for all trials
19 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
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 7, 2017
March 1, 2017
11 months
September 28, 2015
March 3, 2017
Conditions
Keywords
Interventions
Zenith® Branch Endovascular Graft-Iliac Bifurcation (Branch Graft) with the ConnectSX™
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
- Unsuitable arterial anatomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
University of Florida
Gainesville, Florida, 32610, United States
Emory University
Atlanta, Georgia, 30322, 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 Hospital
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
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 FACS
Christine E. Lynn Heart and Vascular Institute
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
October 8, 2015
Study Start
May 1, 2012
Primary Completion
April 1, 2013
Study Completion
October 1, 2017
Last Updated
March 7, 2017
Record last verified: 2017-03