PRESERVE-Zenith® Iliac Branch System Clinical Study
1 other identifier
interventional
40
1 country
19
Brief Summary
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/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
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedResults Posted
Study results publicly available
August 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2017
CompletedApril 4, 2018
September 1, 2017
1.8 years
September 23, 2010
July 18, 2017
March 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients That Are Free From Patency-related Intervention
Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.
6 Months
Study Arms (1)
Device Implant
EXPERIMENTALInterventions
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ 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 (19)
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
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
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
Results Point of Contact
- Title
- Scott Snyder, PhD, Director of Clinical Affairs
- 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
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2010
First Posted
September 24, 2010
Study Start
January 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 10, 2017
Last Updated
April 4, 2018
Results First Posted
August 16, 2017
Record last verified: 2017-09