Fenestrated Endovascular Aortic RepairBRAVE FEVARNCT07424885
BeFlared Versus VBX for FEVAR
A study testing Randomization in people with Fenestrated Endovascular Aortic Repair, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fenestrated Endovascular Aortic Repair
- What is being tested?
- Randomization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteAustria
- Study dates
- 19 Feb 2026to Feb 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- age < 18 years;
- all female patients with a pregnancy possibility (premenopausal)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Sotir, MD contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
Vienna, State of Vienna, 1090
Wolf Hans Eilenberg, MD, PhD, +4369911723838, wolf.eilenberg@meduniwien.ac.at
About this study
Official title: 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.
- Conditions
- Fenestrated Endovascular Aortic Repair
- Being tested
- Randomization
- Keywords
- FEVAR, endovascular aortic repair, bridging stent graft, cannulation, target vessel instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RandomizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BeFlared group | Active comparator | Patients undergoing fenestrated endovascular aortic repair with BeFlared FEVAR Stent Graft System© Receives: Other: Randomization |
| VBX group | Active comparator | Patients undergoing fenestrated aortic repair with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Receives: Other: Randomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: Intraoperative assessment during recruitment period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start19 Feb 2026
- Primary completionFeb 2033 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fenestrated Endovascular Aortic RepairStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolf Eilenberg, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424885
- Sponsor's protocol ID
- 1501/2025
- Acronym
- BRAVE FEVAR
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeFlared FEVAR Stent Graft System© Versus GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for Fenestrated Endovascular Aortic Repair - Randomized Controlled Unblinded Clinical Trial
- ClinicalTrials.gov ID
- NCT07424885
- Acronym / sponsor ID
- BRAVE FEVAR / 1501/2025
- Conditions
- Fenestrated Endovascular Aortic Repair
- Keywords
- FEVAR, endovascular aortic repair, bridging stent graft, cannulation, target vessel instability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Feb 2033 (estimated)
- Study completion
- Feb 2033 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BeFlared group | Active comparator | Other: RandomizationPatients undergoing fenestrated endovascular aortic repair with BeFlared FEVAR Stent Graft System© |
| VBX group | Active comparator | Other: RandomizationPatients undergoing fenestrated aortic repair with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- age < 18 years;
- all female patients with a pregnancy possibility (premenopausal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RandomizationPreinterventional 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. | Other | BeFlared group, VBX group |
Primary outcome
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.
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.
1 secondary outcome
Intraoperative target vessel (TV) success
Time frame: Intraoperative assessment during recruitment period of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Fenestrated Endovascular Aortic Repair
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Recruiting
Laser In Situ Fenestration Study
Aortic Aneurysm, Endovascular Aneurysm Repair
Enrolling by invitationObservational study
Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.
Aortic Aneurysm, Aortic Aneurysm Abdominal
RecruitingObservational study
European Aortic Data Collection Project
Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Enrolling by invitation
Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices
Aortic Aneurysm, Abdominal, Thoracic Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Sotir, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomization in people with Fenestrated Endovascular Aortic Repair, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wolf Hans Eilenberg, MD, PhD (+43 (0)1 40400-69560, wolf.eilenberg@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative device time (time frame: Intraoperative assessment during recruitment period of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.