Zenith® Fenestrated+ Clinical Study

NCT ID: NCT04875429

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-08

Study Completion Date

2031-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

endovascular Vascular Diseases Cardiovascular Diseases Fenestration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aortic abdominal aneurysm

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Endovascular aneurysm repair

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Endovascular aneurysm repair

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gustavo Oderich, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

Site Status

UC San Diego

La Jolla, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Stanford Hospitals and Clinics

Stanford, California, United States

Site Status

Medstar Washington Hospital Center

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

Site Status

University of Florida Shands Hospital

Gainesville, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Edward Hospital

Naperville, Illinois, United States

Site Status

Methodist Hospital of Indiana

Indianapolis, Indiana, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

New York University Langone Medical Center

New York, New York, United States

Site Status

Columbia University Irving Medical Center/NY Presbyterian Hospital

New York, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Holston Valley Hospital

Kingsport, Tennessee, United States

Site Status

Ut Southwestern

Dallas, Texas, United States

Site Status

Memorial Hermann Texas Medical Center/UT Health

Houston, Texas, United States

Site Status

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Site Status

St Thomas' Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-07

Identifier Type: -

Identifier Source: org_study_id