Clinical trial NCT01540643: Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
Official title: Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Keywords: abdominal aortic aneurysm
iliac leg graft
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft

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


Eligibility criteria: 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.

Primary outcomes:
measure: Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Valley Vascular Consultants
state: Alabama
city: Aurora
country: United States
facility: University of Colorado, Anschutz Medical Campus
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Columbia
country: United States
facility: Missouri Heart Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Billings
country: United States
facility: St. Vincent's Heart and Vascular Center
state: Montana
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center Hospital
state: New York
city: Hawthorne
country: United States
facility: Westchester Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Mount Carmel East
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Physican's Regional Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston VA
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Froedert Hospital
state: Wisconsin
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: Thomas Lindsay
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.