MedPath

Zenith® Low Profile AAA Endovascular Graft

Conditions
Abdominal Aortic Aneurysms
Iliac Aneurysms
Aorto-iliac Aneurysms
Registration Number
NCT02557659
Lead Sponsor
Cook Group Incorporated
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
NO_LONGER_AVAILABLE
Sex
All
Target Recruitment
Not specified
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

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (22)

Yale New Haven School of Medicine

🇺🇸

New Haven, Connecticut, United States

William Beaumont Hospital

🇺🇸

Royal Oak, Michigan, United States

University of North Carolina

🇺🇸

Chapel Hill, North Carolina, United States

Stanford University Medical School

🇺🇸

Stanford, California, United States

New York University - Langone Medical Center

🇺🇸

New York, New York, United States

New York Presbyterian - Columbia

🇺🇸

New York, New York, United States

Hospital of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Massachusetss General Hospital

🇺🇸

Boston, Massachusetts, United States

Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

Barnes-Jewish Hospital

🇺🇸

Saint Louis, Missouri, United States

New York Presbyterian Hospital - Cornell

🇺🇸

New York, New York, United States

Ohio Health Research Institute

🇺🇸

Columbus, Ohio, United States

Allegheny General Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

University of Washington-Harborview Medical Center

🇺🇸

Seattle, Washington, 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 Michigan Health System

🇺🇸

Ann Arbor, Michigan, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Aurora Saint Luke's Medical Center

🇺🇸

Milwaukee, Wisconsin, United States

University of Florida

🇺🇸

Gainesville, Florida, United States

Morristown Memorial Hospital

🇺🇸

Morristown, New Jersey, United States

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