Summary

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

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:

  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

  • UC San Diego not yet accepting patients
    La Jolla California 92037 United States
  • University of Southern California accepting new patients
    Los Angeles California 90031 United States
  • Stanford Hospitals and Clinics accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Cook Research Incorporated
ID
NCT04875429
Study Type
Interventional
Participants
Expecting 102 study participants
Last Updated