BeFlared Versus VBX for FEVAR

NCT07424885 | Recruiting DMC

• 1 other identifier: 1501/2025
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fenestrated Endovascular Aortic Repair

Keywords

FEVAR; endovascular aortic repair; bridging stent graft; cannulation; target vessel instability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Intraoperative target vessel (TV) success

  Intraoperative assessment during recruitment period of 2 years

Other Outcomes (1)

• Explorative objectives

  First patient enrolled - last patient completing midterm follow-up

Study Arms (2)

BeFlared group

ACTIVE COMPARATOR

Patients undergoing fenestrated endovascular aortic repair with BeFlared FEVAR Stent Graft System©

Other: Randomization

VBX group

ACTIVE COMPARATOR

Patients undergoing fenestrated aortic repair with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Other: Randomization

Interventions

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.

BeFlared group; VBX group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Random Allocation

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Wolf Hans Eilenberg, MD, PhD

CONTACT

+43 (0)1 40400-69560; wolf.eilenberg@meduniwien.ac.at

Anna Sotir, MD

CONTACT

anna.sotir@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ap. Prof. Priv. Doz. Dr., PhD, FEBVS

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 20, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)