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Zenith® Fenestrated+ Clinical Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Zenith® Fenestrated+ Clinical Study

Zenith® Fenestrated+ Endovascular Graft Clinical Study

NCT04875429•Cook Research Incorporated

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

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

Key Dates

Start Date

December 8, 2023

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2031

Last Updated

February 20, 2026

Enrollment

105

ACTUAL participants

Conditions

Aortic Aneurysm, AbdominalJuxtarenal Aortic AneurysmExtent IV ThoracoabdominalPararenal Aneurysm

Interventions

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

DEVICE

Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology

NCT06969729

Abdominal Aortic AneurysmJuxtarenal Aortic Aneurysm+2 more

View study

RECRUITINGNA

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

NCT04503395

Aortic Aneurysm, Abdominal

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Zenith® Fenestrated+ Clinical Study

Inclusion Criteria

Exclusion Criteria

Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

QoL After Complex Endovascular Aortic Repair

Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms