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NCT04875429NARecruiting

Zenith® Fenestrated+ Clinical Study

Cook Research Incorporated

Start Date

12/8/2023

Completion Date

11/1/2031

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 Criteria

Age Range: 18 years to No maximum

Include Criteria: 1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator Exclusion Criteria: 1. Age \< 18 years 2. Life expectancy \< 2 years 3. Pregnant, breast-feeding, or planning to become pregnant within 60 months 4. Inability or refusal to give informed consent by the patient or legally authorized representative 5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging 6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Interventions

DEVICE

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

Interested in This Trial?

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Conditions

Aortic Aneurysm, AbdominalJuxtarenal Aortic AneurysmExtent IV ThoracoabdominalPararenal Aneurysm

Locations

University of Alabama Birmingham Hospital

Birmingham, Alabama 35294

United States

UC San Diego

La Jolla, California 92037

United States

University of Southern California

Los Angeles, California 90031

United States

Stanford Hospitals and Clinics

Stanford, California 94305

United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

University of Florida Shands Hospital

Gainesville, Florida 32610

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Endeavor Health Cardiovascular Institute at Glenbrook Hospital

Glenview, Illinois 60026

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States

Edward Hospital

Naperville, Illinois 60540

United States

Methodist Hospital of Indiana

Indianapolis, Indiana 46202

United States

University of Maryland

Baltimore, Maryland 21201

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University of Massachusetts

Worcester, Massachusetts 01655

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Barnes Jewish Hospital

St Louis, Missouri 63110

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

New York University Langone Medical Center

New York, New York 10016

United States

Columbia University Irving Medical Center/NY Presbyterian Hospital

New York, New York 10032

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Holston Valley Hospital

Kingsport, Tennessee 37660

United States

Ut Southwestern

Dallas, Texas 75235

United States

Memorial Hermann Texas Medical Center/UT Health

Houston, Texas 77030

United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia 24014

United States

St Thomas' Hospital

London, SE1 7EH

United Kingdom