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RecruitingNot ApplicableNCT07424885

BeFlared Versus VBX for FEVAR

BeFlared FEVAR Stent Graft System© Versus GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for Fenestrated Endovascular Aortic Repair - Randomized Controlled Unblinded Clinical Trial

Sponsor

Medical University of Vienna

Enrollment

126 participants

Start Date

Feb 19, 2026

Study Type

INTERVENTIONAL

Conditions

Fenestrated Endovascular Aortic Repair

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • written informed consent form signed by the patients before admission to the study;
  • age > 18 years;
  • power of judgement and understanding capability of person;
  • patients with juxtarenal, pararenal, paravisceral AAA, EL Type IA with a previous history of EVAR procedure or TAAA (extent I-IV in accordance with Crawford Classification) undergoing emergency/elective treatment with FEVAR (custom-made or off-the-shelf endograft) at the Division of Vascular Surgery, Department of General Surgery, Medical University of Vienna.

Exclusion Criteria2

  • age < 18 years;
  • all female patients with a pregnancy possibility (premenopausal)

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Interventions

OTHERRandomization

Preinterventional randomization of patients to one of two arms - fenestrated endovascular aortic repair with BeFlared FEVAR Stent Graft System© or GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

Locations(1)

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

Vienna, Vienna, Austria

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NCT07424885