Recruiting

Zenith® Fenestrated+

Sponsor:

Cook Research Incorporated

Code:

NCT04875429

Conditions

Aortic Aneurysm, Abdominal

Juxtarenal Aortic Aneurysm

Extent IV Thoracoabdominal

Pararenal Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Conditions

Aortic Aneurysm, Abdominal

Juxtarenal Aortic Aneurysm

Extent IV Thoracoabdominal

Pararenal Aneurysm

Study ID

NCT04875429

Start date

Dec 8, 2023

Status verified date

Mar, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

105 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aortic abdominal aneurysm

Interventions

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

Endovascular aneurysm repair

Primary outcome measure

  • Composite measure of device technical success and procedural safety [ Time Frame: 30 days post procedure ]
  • Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention [ Time Frame: 12 months post procedure ]

Central Contacts and Locations

Central contacts

Chanda Bell, RN, BSN

765-463-7537chanda.bell@cookmedical.com

Maria Soerensen

+45 2868 3248maria.soerensen@cookmedical.com

Locations

University of Alabama Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35294

UC San Diego

Recruiting

La Jolla, California, United States, 92037

University of Southern California

Recruiting

Los Angeles, California, United States, 90031

Stanford Hospitals and Clinics

Recruiting

Stanford, California, United States, 94305

Medstar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

University of Florida Shands Hospital

Recruiting

Gainesville, Florida, United States, 32610

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Endeavor Health Cardiovascular Institute at Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Edward Hospital

Recruiting

Naperville, Illinois, United States, 60540

Principal Investigator:

George Pontikis, MD

Methodist Hospital of Indiana

Recruiting

Indianapolis, Indiana, United States, 46202

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

University of Massachusetts

Recruiting

Worcester, Massachusetts, United States, 01655

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

New York University Langone Medical Center

Recruiting

New York, New York, United States, 10016

Columbia University Irving Medical Center/NY Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Holston Valley Hospital

Recruiting

Kingsport, Tennessee, United States, 37660

Ut Southwestern

Recruiting

Dallas, Texas, United States, 75235

Memorial Hermann Texas Medical Center/UT Health

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Cook Research Incorporated

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • endovascular
  • Vascular Diseases
  • Cardiovascular Diseases
  • Fenestration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cook Research Incorporated on 2026-03-23.