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NCT02557659 Clinical Trial

Zenith® Low Profile AAA Endovascular Graft

Abdominal Aortic Aneurysms Clinical Trial

Official title:
Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft

Clinical Trial Details — Status: No longer available

Administrative data
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

Study information
Verified date March 2018
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zenith Low Profile AAA Endovascular Graft
Treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

United States, 

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