ACTIVE_NOT_RECRUITING

Zenith® Fenestrated+ Clinical Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Quick Facts

Study Start:2023-12-08
Study Completion:2031-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04875429

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Age \< 18 years
  2. 2. Life expectancy \< 2 years
  3. 3. Pregnant, breast-feeding, or planning to become pregnant within 60 months
  4. 4. Inability or refusal to give informed consent by the patient or legally authorized representative
  5. 5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
  6. 6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Contacts and Locations

Principal Investigator

Gustavo Oderich, MD
PRINCIPAL_INVESTIGATOR
Memorial Hermann Texas Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Cook Research Incorporated

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-08
Study Completion Date2031-08

Study Record Updates

Study Start Date2023-12-08
Study Completion Date2031-08

Terms related to this study

Keywords Provided by Researchers

  • endovascular
  • Vascular Diseases
  • Cardiovascular Diseases
  • Fenestration

Additional Relevant MeSH Terms

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