Abdominal Aortic Aneurysms Clinical Trial
Official title:
Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
NCT number | NCT02557659 |
Other study ID # | 08-013 CA |
Secondary ID | |
Status | No longer available |
Phase | N/A |
First received | September 22, 2015 |
Last updated | March 8, 2018 |
Verified date | March 2018 |
Source | Cook Group Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Expanded Access |
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.
Status | No longer available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
United States | Massachusetss General Hospital | Boston | Massachusetts |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Ohio Health Research Institute | Columbus | Ohio |
United States | University of Florida | Gainesville | Florida |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Morristown Memorial Hospital | Morristown | New Jersey |
United States | Yale New Haven School of Medicine | New Haven | Connecticut |
United States | New York Presbyterian - Columbia | New York | New York |
United States | New York Presbyterian Hospital - Cornell | New York | New York |
United States | New York University - Langone Medical Center | New York | New York |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | Mercy Hospital | Saint Louis | Missouri |
United States | University of California San Francisco-VA | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Washington-Harborview Medical Center | Seattle | Washington |
United States | Stanford University Medical School | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Cook Group Incorporated |
United States,
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---|---|---|---|
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