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Zenith® p-Branch® Endovascular Graft Pivotal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02396199
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Abdominal Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith® p-Branch® Pivotal Study
Study Start Date : August 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Endovascular
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Other Names:
  • Endovascular graft
  • Endovascular stent
  • Stent-graft
  • Fenestrated graft

Primary Outcome Measures :
  1. Rate of treatment success [ Time Frame: 12 months ]
    Technical success and freedom from type 1 and type 3 endoleaks, aneurysm growth, related SAE's, and related major complications

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02396199

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Contact: Morgan Griffith 800-468-1379

Hide Hide 33 study locations
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United States, Alabama
University of Alabama Birmingham Hosptial Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
St. Joseph's Hospital and Medical Center-Dignity Health Recruiting
Phoenix, Arizona, United States
United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90024
Kaiser Permanente Recruiting
San Francisco, California, United States, 94115
Stanford University Medical School Recruiting
Stanford, California, United States, 94305
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102-8000
United States, Florida
Boca Raton Community Hospita Recruiting
Boca Raton, Florida, United States, 33486
University of Florida Withdrawn
Gainesville, Florida, United States, 32610
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33601
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
United States, Indiana
Methodist Hospital of Indiana Recruiting
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Withdrawn
Boston, Massachusetts, United States, 02462
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Beaumont Hospital Royal Oak Withdrawn
Troy, Michigan, United States, 48083
United States, Minnesota
Minneapolis Heart Inst. Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes Jewish Hospital Plaza Recruiting
Saint Louis, Missouri, United States, 63110
Mercy Hospital St. Louis Recruiting
Saint Louis, Missouri, United States, 63141
United States, New York
New York University - Langone Medical Center Recruiting
New York, New York, United States, 10016
Mount Sinai Roosevelt Recruiting
New York, New York, United States, 10025
United States, North Carolina
University of North Carolina Withdrawn
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation Withdrawn
Cleveland, Ohio, United States, 44195
United States, Oregon
Bend Memorial Clinic Withdrawn
Bend, Oregon, United States, 97701
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75235
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
The Methodist Hospital - Smith Tower Recruiting
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Hospital and Clinics Withdrawn
Madison, Wisconsin, United States, 53711
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Cook Research Incorporated
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Principal Investigator: Mark A Farber, MD University of North Carolina
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Responsible Party: Cook Research Incorporated Identifier: NCT02396199    
Other Study ID Numbers: 14-09
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Abdominal aortic aneurysm
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases