Zenith® Fenestrated+ Clinical Study

a study on Abdominal Aortic Aneurysm Aneurysm Extent IV Thoracoabdominal

Eligibility: for people ages 18 years and up (full criteria)
Location: at La Jolla, California and other locations
Dates: study started December 2023
completion around April 2031

Description

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.

Official Title

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Keywords

Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm, endovascular, Vascular Diseases, Cardiovascular Diseases, Fenestration, Aneurysm, Aortic Aneurysm, Abdominal Aortic Aneurysm, Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2, Aortic abdominal aneurysm

Eligibility

For people ages 18 years and up

Include Criteria:

Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
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:

Age < 18 years
Life expectancy < 2 years
Pregnant, breast-feeding, or planning to become pregnant within 60 months
Inability or refusal to give informed consent by the patient or legally authorized representative
Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

Locations

UC San Diego accepting new patients
La Jolla California 92037 United States
University of Southern California accepting new patients
Los Angeles California 90031 United States

Details

Status: accepting new patients
Start Date: December 2023
Completion Date: April 2031 (estimated)
Sponsor: Cook Research Incorporated
ID: NCT04875429
Study Type: Interventional
Participants: Expecting 102 study participants
Last Updated: March 24, 2025

I’m interested in this study!