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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 23, 2012
Last updated: September 8, 2015
Last verified: September 2015
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.

Condition Intervention
Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Device: Iliac Leg Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Abdominal aortic aneurysm Device: Iliac Leg Graft
Zenith® Spiral-Z® AAA Iliac Leg Graft


Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Miami Hospital
Miami, Florida, United States, 33136
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140-2948
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
Principal Investigator: Thomas Lindsay Toronto General Hospital
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01540643     History of Changes
Other Study ID Numbers: 11-015
Study First Received: February 23, 2012
Last Updated: September 8, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Cook:
abdominal aortic aneurysm
iliac leg graft

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

ClinicalTrials.gov processed this record on November 27, 2015