This study is in progress, not accepting new patients

Zenith® p-Branch® Endovascular Graft Pivotal Study

a study on Aneurysm Abdominal Aortic Aneurysm

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Steven Farley (ucla)

Description

Summary

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Official Title

Zenith® p-Branch® Pivotal Study

Keywords

Aortic Aneurysm Abdominal, Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated, Aneurysm, Aortic Aneurysm, Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
  • Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
  • Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation

You CAN'T join if...

  • Age <18 years
  • Life expectancy <2 years
  • Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
  • Inability or refusal to give informed consent by the patient or a legally authorized representative
  • Unwilling or unable to comply with the follow-up schedule
  • Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
  • Additional medical restrictions as specified in the Clinical Investigation Plan
  • Additional anatomical restrictions as specified in the Clinical Investigation Plan

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90024 United States
  • Kaiser Permanente
    San Francisco California 94115 United States
  • Stanford University Medical School
    Stanford California 94305 United States

Lead Scientist at University of California Health

  • Steven Farley (ucla)
    Hs Clinical Professor, Surgery, Medicine. Authored (or co-authored) 24 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cook Research Incorporated
ID
NCT02396199
Study Type
Interventional
Participants
About 80 people participating
Last Updated