Zenith® p-Branch® Endovascular Graft Pivotal Study
Zenith® p-Branch® Pivotal Study
1 other identifier
interventional
80
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedResults Posted
Study results publicly available
October 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2025
CompletedFebruary 19, 2025
February 1, 2025
5.7 years
March 12, 2015
August 9, 2022
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Success Proportion
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
12 months
Study Arms (1)
Endovascular
EXPERIMENTALEndovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
University of Alabama Birmingham Hosptial
Birmingham, Alabama, 35233, United States
St. Joseph's Hospital and Medical Center-Dignity Health
Phoenix, Arizona, 85013, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024, United States
Kaiser Permanente
San Francisco, California, 94115, United States
Stanford University Medical School
Stanford, California, 94305, United States
Hartford Hospital
Hartford, Connecticut, 06102-8000, United States
Boca Raton Community Hospita
Boca Raton, Florida, 33486, United States
Tampa General Hospital
Tampa, Florida, 33601, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Minneapolis Heart Inst. Foundation
Minneapolis, Minnesota, 55407, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Barnes Jewish Hospital Plaza
St Louis, Missouri, 63110, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
New York University - Langone Medical Center
New York, New York, 10016, United States
Mount Sinai Roosevelt
New York, New York, 10025, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
UT Southwestern
Dallas, Texas, 75235, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
The Methodist Hospital - Smith Tower
Houston, Texas, 77030, United States
Baylor Scott and White Research Institute
Irving, Texas, 75061, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Saunders, MS, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Farber, MD
University of North Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 24, 2015
Study Start
August 1, 2015
Primary Completion
April 1, 2021
Study Completion
January 28, 2025
Last Updated
February 19, 2025
Results First Posted
October 25, 2022
Record last verified: 2025-02