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NCT Number: NCT07424885

BeFlared Versus VBX for FEVAR

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.

Recruiting

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Key information

Conditions

Fenestrated Endovascular Aortic Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Wolf Hans Eilenberg, MD, PhD

CONTACT

[email protected]

+4369911723838

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

Randomization

Other

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.

Primary outcomes

  1. Cumulative device time

    Time frame: Intraoperative assessment during recruitment period of 2 years

    Cumulative device time (measured in minutes) is defined as time between introduction of bridging stent graft (BSG) system into sheath and successful removal of deflated BSG flaring balloon for each of target vessels.

  2. Target vessel (TV) instability at follow-up

    Time frame: Early follow-up of first patients enrolled - end of midterm follow-up of last patients enrolled

    TV instability at early, short-term and midterm follow up - defined as any death or aneurysm rupture event related to TV complication (e.g. TV endoleak or rupture) or any secondary intervention indicated to treat a TV related complication, including TV endoleak, disconnection, kinking, stenosis, occlusion, or rupture.

    Early follow-up is defined as radiological and clinical follow-up of the patients within the first 30 postoperative days or withing the hospital stay if longer than 30 days. Short-term follow-up encompass follow-up between 30 days and 6 months. Midterm follow-up refer to follow-up that occur within 6 months to 5 years after FEVAR procedure.

Secondary outcomes

  1. Intraoperative target vessel (TV) success

    Time frame: Intraoperative assessment during recruitment period of 2 years

    Intraoperative target vessel (TV) technical success is defined as successful TV catheterization and placement of bridging stent graft (BSG) with restoration and maintenance of flow in all intended TVs.

Other outcomes

  1. Explorative objectives

    Time frame: First patient enrolled - last patient completing midterm follow-up

    Procedural metrics (operation time [minutes], dose of area product [Gy cm2], fluoroscopy time [minutes], dose of contrast agent applied [mL], intraoperative blood loss [mL]), duration of intensive care unit stay, TV patency, TV related endoleak formation, secondary TV related reinterventions as well as major adverse events (all-cause mortality, myocardial infarction, renal events, mesenteric events, respiratory events) at early, short-term and midterm postoperative outcome in patients undergoing FEVAR procedure with BeFlared or VBX bridging device will comprise explorative objectives (parameters) of this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Sotir, MD

CONTACT

[email protected]

Wolf Hans Eilenberg, MD, PhD

CONTACT

[email protected]

+43 (0)1 40400-69560

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: BRAVE FEVAR

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Feb 20, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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