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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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
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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Rochester, MN
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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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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Gainesville, FL
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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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Philadelphia, PA
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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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Portland, OR
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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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Tampa, FL
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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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Atlanta, GA
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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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Baltimore, MD
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Bend, Oregon 97701
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Bend, OR
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Birmingham, Alabama 35233
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Birmingham, AL
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Boca Raton, Florida 33486
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Boca Raton, FL
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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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Chapel Hill, NC
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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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Cleveland, OH
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Dallas, Texas 75390
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Dallas, TX
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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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Durham, NC
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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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Hartford, CT
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Houston, TX
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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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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Los Angeles, California 90095
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Los Angeles, CA
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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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Madison, WI
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Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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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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New York, NY
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New York, New York 10019
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New York, NY
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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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Pittsburgh, PA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Saint Louis, Missouri 63141
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Saint Louis, MO
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San Francisco, California 94115
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San Francisco, CA
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Stanford, California 94305
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Stanford, CA
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Troy, Michigan 48083
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Troy, MI
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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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Worcester, MA
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