Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

January 19, 2017 updated by: Cook Group Incorporated
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Civic Campus
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Valley Vascular Consultants
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Anschutz Medical Campus
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Miami Beach, Florida, United States, 33140-2948
        • Mount Sinai Medical Center
    • Georgia
      • Augusta, Georgia, United States, 30901
        • University Hospital
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Heart Center
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, United States, 59101
        • St. Vincent's Heart and Vascular Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Robert Wood Johnson University Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center Hospital
      • Hawthorne, New York, United States, 10532
        • Westchester Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 25157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18045
        • St. Luke's University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Physican's Regional Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Houston VA
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center Everett
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedert Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft

Description

Inclusion Criteria:

  • Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.

Exclusion Criteria:

  • Patients for whom this device would not normally be considered standard of care.

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?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Abdominal aortic aneurysm
Device: Iliac Leg Graft
Zenith® Spiral-Z® AAA Iliac Leg Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Thomas Lindsay, Toronto General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (ESTIMATE)

February 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-015

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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