Zenith® p-Branch® Endovascular Graft Pivotal Study

Completed · Not applicable

Conditions studied: Aortic Aneurysm Abdominal

In brief

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.

Key facts

Study ID

NCT02396199

Run by

Cook Research Incorporated

People needed

80

Starts

2015-08-01

Expected to finish

2025-01-28

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama Birmingham Hosptial — Birmingham, Alabama, United States
• St. Joseph's Hospital and Medical Center-Dignity Health — Phoenix, Arizona, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Kaiser Permanente — San Francisco, California, United States
• Stanford University Medical School — Stanford, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Boca Raton Community Hospita — Boca Raton, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Methodist Hospital of Indiana — Indianapolis, Indiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Minneapolis Heart Inst. Foundation — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Barnes Jewish Hospital Plaza — St Louis, Missouri, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States
• New York University - Langone Medical Center — New York, New York, United States
• Mount Sinai Roosevelt — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• UT Southwestern — Dallas, Texas, United States
• Michael E. DeBakey VA Medical Center — Houston, Texas, United States
• The Methodist Hospital - Smith Tower — Houston, Texas, United States

Full record on ClinicalTrials.gov

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