PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

NCT ID: NCT02475798

Last Updated: 2020-12-16

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

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.

Detailed Description

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Conditions

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Aortoiliac Aneurysms Iliac Aneurysms

Keywords

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Zenith aortoiliac aneurysm Iliac aneurysm Branch Connections Endovascular graft Graft-iliac bifurcation Aneurysm Vascular Diseases Cardiovascular Diseases

Interventions

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Zenith® Branch Endovascular Graft-Iliac Bifurcation,

Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.

Intervention Type DEVICE

Other Intervention Names

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Branch Graft

Eligibility Criteria

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Inclusion Criteria

* An aortoiliac or iliac aneurysm of appropriate size
* Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W. Anthony Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Christine E. Lynn Heart and Vascular Institute

Locations

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Mayo Foundation for Medical Education and Research

Phoenix, Arizona, United States

Site Status

VA Palo Alto HCS

Palo Alto, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

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Christine E. Lynn Heart and Vascular Institute

Boca Raton, Florida, United States

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South Florida Medical Imaging

Fort Lauderdale, Florida, United States

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University of Florida

Gainesville, Florida, United States

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Emory University

Atlanta, Georgia, United States

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St. Anthony's Medical Center

Rockford, Illinois, United States

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Methodist Hospital of Indiana

Indianapolis, Indiana, United States

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University of Kentucky Hospital

Lexington, Kentucky, United States

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University of Massachusetts

Worcester, Massachusetts, United States

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William Beaumont Hospital

Royal Oak, Michigan, United States

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Mayo Clinic

Rochester, Minnesota, United States

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Washington University School of Medicine

St Louis, Missouri, United States

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Mercy Hospital East Communities

St Louis, Missouri, United States

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

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Columbia University Medical Center

New York, New York, United States

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Weill Cornell Medical Center

New York, New York, United States

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University of North Carolina

Chapel Hill, North Carolina, United States

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

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Medical University of South Carolina

Charleston, South Carolina, United States

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UT Southwestern

Dallas, Texas, United States

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University of Virginia

Charlottesville, Virginia, United States

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Aurora St. Luke's Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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05-625 CA-P2

Identifier Type: -

Identifier Source: org_study_id