Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
1 other identifier
observational
600
2 countries
31
Brief Summary
The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 20, 2017
January 1, 2017
4 years
February 23, 2012
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft.
12 months
Study Arms (1)
Abdominal aortic aneurysm
Interventions
Eligibility Criteria
Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft
You may qualify if:
- Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.
You may not qualify if:
- Patients for whom this device would not normally be considered standard of care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Valley Vascular Consultants
Huntsville, Alabama, 35801, United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140-2948, United States
University Hospital
Augusta, Georgia, 30901, United States
Missouri Heart Center
Columbia, Missouri, 65201, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
St. Vincent's Heart and Vascular Center
Billings, Montana, 59101, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Albany Medical Center Hospital
Albany, New York, 12208, United States
Westchester Medical Center
Hawthorne, New York, 10532, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 25157, United States
Mount Carmel East
Columbus, Ohio, 43213, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18045, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Physican's Regional Medical Center
Knoxville, Tennessee, 37909, United States
Houston VA
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Froedert Hospital
Milwaukee, Wisconsin, 53226, United States
Hamilton General Hospital
Hamilton, Ontario, L8L2X2, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Ottawa Hospital Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
Lindsay T, Jazaeri O, Sherman SM, Saunders AT, Forbes TL; Spiral-Z Registry Investigators. Final results from a postmarket registry of an iliac leg graft with a continuous, spiral nitinol stent. J Vasc Surg. 2020 Aug;72(2):576-583.e1. doi: 10.1016/j.jvs.2019.10.078. Epub 2020 Jan 19.
PMID: 31964568DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Lindsay
Toronto General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 20, 2017
Record last verified: 2017-01