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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540643
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : January 20, 2017
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Aorto-iliac Aneurysm Device: Iliac Leg Graft

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
Study Start Date : March 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540643

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

Responsible Party: Cook Group Incorporated Identifier: NCT01540643     History of Changes
Other Study ID Numbers: 11-015
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Cook Group Incorporated:
abdominal aortic aneurysm
iliac leg graft

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases