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

NCT ID: NCT01540643

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm Aorto-iliac Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominal aortic aneurysm

Iliac Leg Graft

Intervention Type DEVICE

Zenith® Spiral-Z® AAA Iliac Leg Graft

Interventions

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Iliac Leg Graft

Zenith® Spiral-Z® AAA Iliac Leg Graft

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Lindsay

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital

Locations

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Valley Vascular Consultants

Huntsville, Alabama, United States

Site Status

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of Miami Hospital

Miami, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

University Hospital

Augusta, Georgia, United States

Site Status

Missouri Heart Center

Columbia, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

St. Vincent's Heart and Vascular Center

Billings, Montana, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Albany Medical Center Hospital

Albany, New York, United States

Site Status

Westchester Medical Center

Hawthorne, New York, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Mount Carmel East

Columbus, Ohio, United States

Site Status

Bend Memorial Clinic

Bend, Oregon, United States

Site Status

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Physican's Regional Medical Center

Knoxville, Tennessee, United States

Site Status

Houston VA

Houston, Texas, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Providence Regional Medical Center Everett

Everett, Washington, United States

Site Status

Charleston Area Medical Center

Charleston, West Virginia, United States

Site Status

Froedert Hospital

Milwaukee, Wisconsin, United States

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Ottawa Hospital Civic Campus

Ottawa, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 31964568 (View on PubMed)

Other Identifiers

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11-015

Identifier Type: -

Identifier Source: org_study_id

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