Zenith® Low Profile AAA Endovascular Graft

March 8, 2018 updated by: Cook Group Incorporated

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

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94143-001
        • University of California San Francisco-VA
      • Stanford, California, United States, 94305
        • Stanford University Medical School
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetss General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6095
        • Morristown Memorial Hospital
    • New York
      • New York, New York, United States, 10016
        • New York University - Langone Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital - Cornell
      • New York, New York, United States, 10065-4870
        • New York Presbyterian - Columbia
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington-Harborview Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (ESTIMATE)

September 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-013 CA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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