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Clinical Trials in the USA / NCT04875429
Recruiting Not applicable

Zenith® Fenestrated+ Clinical Study

NCT04875429 · tracked via the Priya Life Science USA tracker
Sponsor
Cook Research Incorporated
Phase
Not applicable
Started
2023-12-08
Last updated
2026-10-06

Condition(s) studied

Aortic Aneurysm, AbdominalJuxtarenal Aortic AneurysmExtent IV ThoracoabdominalPararenal Aneurysm

Investigational drug(s) / intervention(s)

Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2

Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2: Endovascular aneurysm repair

Study 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.

Up to 130 additional subjects may be enrolled in Continued Access phase of the study

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite measure of device technical success and procedural safety — 30 days post procedure
    Percent of patients with device technical success and freedom from procedural safety events in the following criteria: 1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and 2. Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
  • Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention — 12 months post procedure
    Percent of patients meeting the following criteria: 1. Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and 2. Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)

Trial sites (33)

FacilityCityRegionStatus
University of Alabama Birmingham Hospital Birmingham Alabama Recruiting
UC San Diego La Jolla California Recruiting
University of Southern California Los Angeles California Recruiting
Stanford Hospitals and Clinics Stanford California Recruiting
Medstar Washington Hospital Center Washington D.C. District of Columbia Recruiting
University of Florida Shands Hospital Gainesville Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting
Emory University Hospital Atlanta Georgia Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Endeavor Health Cardiovascular Institute at Glenbrook Hospital Glenview Illinois Recruiting
Loyola University Medical Center Maywood Illinois Recruiting
Edward Hospital Naperville Illinois Recruiting
Methodist Hospital of Indiana Indianapolis Indiana Recruiting
University of Maryland Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Completed
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
University of Massachusetts Worcester Massachusetts Recruiting
University of Michigan Health System Ann Arbor Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Barnes Jewish Hospital St Louis Missouri Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Recruiting
New York University Langone Medical Center New York New York Recruiting
Columbia University Irving Medical Center/NY Presbyterian Hospital New York New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Holston Valley Hospital Kingsport Tennessee Recruiting
Ut Southwestern Dallas Texas Recruiting
Memorial Hermann Texas Medical Center/UT Health Houston Texas Recruiting
Carilion Roanoke Memorial Hospital Roanoke Virginia Active Not Recruiting
St Thomas' Hospital London United Kingdom Active Not Recruiting

More Cook Research Incorporated trials in the USA

Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial Recruiting

Other trials for the same condition

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms Active, not recruiting
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04875429 on ClinicalTrials.gov ↗ ← All trials in the USA