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Zenith® Fenestrated+ Clinical Study

NCT04875429 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-03-23

No results posted yet for this 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 60 additional subjects may be enrolled in Continued Access phase of the study

Conditions

  • Aortic Aneurysm, Abdominal
  • Juxtarenal Aortic Aneurysm
  • Extent IV Thoracoabdominal
  • Pararenal Aneurysm

Interventions

DEVICE

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

Endovascular aneurysm repair

Sponsors & Collaborators

  • Cook Research Incorporated

    lead INDUSTRY

Principal Investigators

  • Gustavo Oderich, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2026-11-30
Completion
2031-11-30
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875429 on ClinicalTrials.gov