Zenith® Fenestrated+ Clinical Study

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Zenith® Fenestrated+ Clinical Study

Condition
Aortic Aneurysm, Abdominal
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham Hospital, Birmingham, Alabama, United States, 35294

La Jolla

UC San Diego, La Jolla, California, United States, 92037

Los Angeles

University of Southern California, Los Angeles, California, United States, 90031

Stanford

Stanford Hospitals and Clinics, Stanford, California, United States, 94305

Washington

Medstar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Gainesville

University of Florida Shands Hospital, Gainesville, Florida, United States, 32610

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Maywood

Loyola University Medical Center, Maywood, Illinois, United States, 60153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cook Research Incorporated,

Gustavo Oderich, MD, PRINCIPAL_INVESTIGATOR, Memorial Hermann Texas Medical Center

Study Record Dates

2031-04