RecruitingNot ApplicableNCT04875429

Zenith® Fenestrated+ Clinical Study

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Sponsor

Cook Research Incorporated

Enrollment

105 participants

Start Date

Dec 8, 2023

Study Type

INTERVENTIONAL

Conditions

Juxtarenal Aortic Aneurysm Aortic Aneurysm, Abdominal Pararenal Aneurysm Extent IV Thoracoabdominal

Summary

The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Up to 60 additional subjects may be enrolled in Continued Access phase of the study

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical study is investigating "Zenith® Fenestrated+ Clinical Study". Researchers are looking for volunteers to help improve understanding and treatments in this area. You may be eligible if: - You are at least 18 Years - Include Criteria: - Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females - Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months You may NOT be eligible if: - Age < 18 years - Life expectancy < 2 years - Pregnant, breast-feeding, or planning to become pregnant within 60 months - Inability or refusal to give informed consent by the patient or legally authorized representative - Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging - Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEZenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2

Endovascular aneurysm repair

Locations(33)

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

UC San Diego

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

Stanford Hospitals and Clinics

Stanford, California, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida Shands Hospital

Gainesville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Endeavor Health Cardiovascular Institute at Glenbrook Hospital

Glenview, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Edward Hospital

Naperville, Illinois, United States

Methodist Hospital of Indiana

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

New York University Langone Medical Center

New York, New York, United States

Columbia University Irving Medical Center/NY Presbyterian Hospital

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Holston Valley Hospital

Kingsport, Tennessee, United States

Ut Southwestern

Dallas, Texas, United States

Memorial Hermann Texas Medical Center/UT Health

Houston, Texas, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

St Thomas' Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04875429

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