Zenith® Low Profile AAA Endovascular Graft
Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
1 other identifier
interventional
62
2 countries
37
Brief Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
37 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
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 26, 2015
CompletedFirst Posted
Study publicly available on registry
August 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2017
CompletedResults Posted
Study results publicly available
June 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2021
CompletedApril 19, 2022
March 1, 2022
2.5 years
August 26, 2015
April 11, 2018
March 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients Without Major Adverse Events Within 30 Days
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
30 days
Number of Patients With Device Success
Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm
12 months
Study Arms (1)
Endovascular Graft
EXPERIMENTALThe Zenith Low Profile AAA Endovascular Graft and ancillary components
Interventions
Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
Eligibility Criteria
You may qualify if:
- Subject has at least one of the following
- Aortic or aortoiliac aneurysm
- Iliac aneurysm
- Aneurysm with a history of growth
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 of breastfeeding or planning on becoming pregnant with 60 months
- Unwilling to comply with the follow-up schedule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
University of Florida
Gainesville, Florida, 32610, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Baptist Health Louisville
Louisville, Kentucky, 40207, United States
Massachusetts General
Boston, Massachusetts, 02114, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Wm Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Missouri Heart Center
Columbia, Missouri, 65201, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
St. Vincent's Heart and Vascular Center
Billings, Montana, 59101, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
New York University - Langone Medical Center
New York, New York, 10016, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY at Stony Brook Hospital
Stony Brook, New York, 11794, United States
SUNY Upstate
Syracuse, New York, 13210, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 25157, United States
Summa Akron
Akron, Ohio, 44309, United States
Good Samaritan-Trihealth
Cincinnati, Ohio, 45220, United States
Bend Memorial Clinic
Bend, Oregon, 97701, 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, 15232, United States
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120, United States
Sentara Vascular Specialists
Norfolk, Virginia, 23507, United States
University of Washington-Harborview Medical Center
Seattle, Washington, 98104, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Aspirus Wausau
Wausau, Wisconsin, 54401, United States
Hamilton General Hospital
Hamilton, Ontario, L8L2X2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Biostatistics
- Organization
- Cook Research Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
August 26, 2015
First Posted
August 28, 2015
Study Start
August 1, 2014
Primary Completion
January 23, 2017
Study Completion
January 27, 2021
Last Updated
April 19, 2022
Results First Posted
June 6, 2018
Record last verified: 2022-03