Clinical trial NCT02557659: Zenith® Low Profile AAA Endovascular Graft
Official title: Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Abdominal Aortic Aneurysms
Iliac Aneurysms
Aorto-iliac Aneurysms
Keywords: Low Profile
Abdominal Aortic Aneurysms
Endovascular
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-09-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.


Eligibility criteria: Inclusion Criteria:

•Subject has at least one of the following

* Aortic or aortoiliac aneurysm
* Iliac aneurysm
* Aneurysm with a history of growth

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco-VA
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical School
state: California
city: New Haven
country: United States
facility: Yale New Haven School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Boston
country: United States
facility: Massachusetss General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: New York University - Langone Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell
state: New York
city: New York
country: United States
facility: New York Presbyterian - Columbia
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington-Harborview Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: Ronald Fairman, MD
role: PRINCIPAL_INVESTIGATOR
References: