Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07424885

BeFlared Versus VBX for FEVAR

Led by Medical University of Vienna · Updated on 2026-02-27

126

Participants Needed

1

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized controlled unblinded trial aimes to compare BeFlared FEVAR Stent Graft System (BeFlared) with GORE® VIABAHN® VBX Balloon Expandable Endoprothesis (VBX) in patients undergoing endovascular aneurysm repair with fenestrated device (FEVAR). Primary objectives: * compare cumulative device time between patients undergoing FEVAR with BeFlared and VBX brindging device; * compare target vessel (TV) instability at early, short-term and midterm follow-up in patients undergoing FEVAR with BeFlared and VBX brindging device. Secondary objectives: \- compare intraoperative TV technical success in patients undergoing FEVAR with BeFlared and VBX bridging device.

CONDITIONS

Official Title

BeFlared Versus VBX for FEVAR

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form before joining the study
  • Age over 18 years
  • Ability to understand and make decisions about participation
  • Patients with juxtarenal, pararenal, paravisceral abdominal aortic aneurysm, EL Type IA with previous EVAR, or thoracoabdominal aneurysm (extent I-IV by Crawford Classification) undergoing emergency or elective FEVAR with custom-made or off-the-shelf endograft at the Medical University of Vienna
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Female patients who could become pregnant (premenopausal)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

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Research Team

W

Wolf Hans Eilenberg, MD, PhD

CONTACT

A

Anna Sotir, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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