Zenith® p-Branch® Endovascular Graft Pivotal Study



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/20/2019
Start Date:August 2015
End Date:November 2025
Contact:Morgan Griffith
Email:morgan.griffith@cookmedical.com
Phone:800-468-1379

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Trial Summary
Trial Overview
Inclusion Criteria

Zenith® p-Branch® Pivotal Study

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety
and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium
iCAST™ covered stents in the treatment of abdominal aortic aneurysms.


Inclusion Criteria:

- Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter

- Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year

- Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic
diameter that is deemed to be at risk for rupture based upon physician interpretation

Exclusion Criteria:

- Age <18 years

- Life expectancy <2 years

- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months

- Inability or refusal to give informed consent by the patient or a legally authorized
representative

- Unwilling or unable to comply with the follow-up schedule

- Simultaneously participating in another investigative device or drug study. (The
patient must have completed the primary endpoint of any previous study at least 30
days prior to enrollment in this study.)

- Additional medical restrictions as specified in the Clinical Investigation Plan

- Additional anatomical restrictions as specified in the Clinical Investigation Plan
We found this trial at
32
sites
Bend Memorial Clinic
Bend, Oregon 97701
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Bend, OR
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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from
Boston, MA
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University of Florida
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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from
Gainesville, FL
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Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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from
Philadelphia, PA
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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mi
from
Portland, OR
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Tampa General Hospital
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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from
Tampa, FL
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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from
Atlanta, GA
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Johns Hopkins Hospital
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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from
Baltimore, MD
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University of Alabama Birmingham Hosptial
Birmingham, Alabama 35233
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from
Birmingham, AL
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Boca Raton Community Hospita
Boca Raton, Florida 33486
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from
Boca Raton, FL
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Univ of North Carolina
Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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from
Chapel Hill, NC
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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from
Cleveland, OH
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UT Southwestern
Dallas, Texas 75390
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from
Dallas, TX
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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from
Durham, NC
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The Hartford Hospital
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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from
Hartford, CT
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The Methodist Hospital - Smith Tower
Houston, Texas 77030
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from
Houston, TX
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Michael E. Debakey VA Medical Center
2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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from
Houston, TX
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Methodist Hospital of Indiana
Indianapolis, Indiana 46202
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from
Indianapolis, IN
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Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
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from
Los Angeles, CA
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University of Wisconsin Hospital and Clinics
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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from
Madison, WI
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Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin 53215
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from
Milwaukee, WI
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Minneapolis Heart Inst. Foundation
Minneapolis, Minnesota 55407
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from
Minneapolis, MN
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New York University Langone Medical Center
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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from
New York, NY
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Mount Sinai Roosevelt
New York, New York 10019
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from
New York, NY
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University of Pittsburgh Medical Center
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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from
Pittsburgh, PA
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Mayo Clinic Rochester
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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from
Rochester, MN
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Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
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from
Saint Louis, MO
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Mercy Hospital, St. Louis
Saint Louis, Missouri 63141
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from
Saint Louis, MO
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Kaiser Permanente
San Francisco, California 94115
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from
San Francisco, CA
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Stanford University Medical School
Stanford, California 94305
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from
Stanford, CA
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Beaumont Hospital Royal Oak
Troy, Michigan 48083
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from
Troy, MI
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Univ of Massachusetts Med School
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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from
Worcester, MA
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