RECRUITING
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Zenith® Fenestrated+ Clinical Study
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 Start (Actual) 8 December 2023
🗓️ Primary Completion (Estimated) June 2026
✅ Study Completion (Estimated) April 2031
👥 Enrollment (Estimated) 102
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 La Jolla, California, United States
📍 Los Angeles, California, United States
📍 Stanford, California, United States
📍 Washington, District of Columbia, United States
📍 Gainesville, Florida, United States
📍 Tampa, Florida, United States
📍 Atlanta, Georgia, United States
📍 Chicago, Illinois, United States
📍 Maywood, Illinois, United States
📍 Naperville, Illinois, United States
📍 Indianapolis, Indiana, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Worcester, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Rochester, Minnesota, United States
📍 Saint Louis, Missouri, United States
📍 Lebanon, New Hampshire, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Cleveland, Ohio, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 Dallas, Texas, United States
📍 Houston, Texas, United States
📍 Roanoke, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 19 April 2021
  • First Submitted that Met QC Criteria 4 May 2021
  • First Posted 6 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 July 2024
  • Last Update Posted 23 July 2024
  • Last Verified July 2024
I'm interested ...!!