BeFlared Versus VBX for FEVAR (BRAVE FEVAR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fenestrated Endovascular Aortic Repair
• Intervention / Treatment: Other: Randomization

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wolf Hans Eilenberg, MD, PhD; Phone Number: +43 (0)1 40400-69560; Email: wolf.eilenberg@meduniwien.ac.at
• Study Contact Backup: Name: Anna Sotir, MD; Email: anna.sotir@meduniwien.ac.at

Study Locations

• Austria
  • Vienna
    • Vienna, Vienna, Austria, 1090
      • Recruiting
      • Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
      • Contact: Wolf Hans Eilenberg, MD, PhD; Phone Number: +4369911723838; Email: wolf.eilenberg@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BeFlared group; Patients undergoing fenestrated endovascular aortic repair with BeFlared FEVAR Stent Graft System©	Other: Randomization; 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.
Active Comparator: VBX group; Patients undergoing fenestrated aortic repair with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis	Other: Randomization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative device time	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.	Intraoperative assessment during recruitment period of 2 years
Target vessel (TV) instability at follow-up	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.	Early follow-up of first patients enrolled - end of midterm follow-up of last patients enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative target vessel (TV) success	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.	Intraoperative assessment during recruitment period of 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explorative objectives	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.	First patient enrolled - last patient completing midterm follow-up

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cannulation; FEVAR; endovascular aortic repair; bridging stent graft; target vessel instability
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Random Allocation
• Other Study ID Numbers: 1501/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No