Fenestrated AAA Endovascular Graft Post-Approval Study
Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study
1 other identifier
interventional
21
1 country
6
Brief Summary
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
6 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
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedResults Posted
Study results publicly available
September 14, 2021
CompletedOctober 5, 2021
September 1, 2021
6.6 years
November 18, 2013
August 17, 2021
September 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Success : AAA Related Mortality
patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,
5 years
Study Arms (1)
Zenith® Fenestrated AAA Endovascular Graft
EXPERIMENTALInterventions
The Zenith® Fenestrated AAA Endovascular Graft with the H\&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair
Eligibility Criteria
You may qualify if:
- abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
- aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair
You may not qualify if:
- proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
- renal artery stenosis greater than 50 percent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of California-Davis
Sacramento, California, 95817, United States
University of Colorado
Aurora, Colorado, 80045, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Wake Forest University Health
Winston-Salem, North Carolina, 27102, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53711, United States
MeSH Terms
Conditions
Results Point of Contact
- Title
- Alan Saunders, MS, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
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
November 18, 2013
First Posted
November 25, 2013
Study Start
March 1, 2014
Primary Completion
October 12, 2020
Study Completion
October 12, 2020
Last Updated
October 5, 2021
Results First Posted
September 14, 2021
Record last verified: 2021-09