Zenith® Low Profile AAA Endovascular Graft
Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
1 other identifier
expanded_access
N/A
1 country
22
Brief Summary
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
22 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
First Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedMarch 12, 2018
March 1, 2018
September 22, 2015
March 8, 2018
Conditions
Keywords
Interventions
Treatment of patients with abdominal aortic, aorto-iliac, 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
- Life expectancy less than 2 years
- 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 (22)
University of California San Francisco-VA
San Francisco, California, 94143-001, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Stanford University Medical School
Stanford, California, 94305, United States
Yale New Haven School of Medicine
New Haven, Connecticut, 06510, United States
University of Florida
Gainesville, Florida, 32610, United States
Massachusetss General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960-6095, United States
New York University - Langone Medical Center
New York, New York, 10016, United States
New York Presbyterian Hospital - Cornell
New York, New York, 10032, United States
New York Presbyterian - Columbia
New York, New York, 10065-4870, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Washington-Harborview Medical Center
Seattle, Washington, 98104, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Fairman, MD
University of Pennsylvania
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 23, 2015
Last Updated
March 12, 2018
Record last verified: 2018-03