BeFlared versus VBX as bridging stents for fenestrated endovascular aortic repair
Official title: BeFlared FEVAR Stent Graft System© Versus GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for Fenestrated Endovascular Aortic Repair - Randomized Controlled Unblinded Clinical Trial
Run by Medical University of Vienna · NCT07424885 · Data updated 2026-11-12
This compares the BeFlared and VBX stent grafts as bridging devices for adults having fenestrated endovascular aortic repair to see which gives shorter device time and more stable target vessels.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Status | Recruiting |
| Started | February 19, 2026 |
| Main results expected | February 2033 |
| Study ends | February 2033 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07424885 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 who can give informed consent and are undergoing elective or emergency FEVAR for juxtarenal, pararenal, paravisceral AAA, EL Type IA after prior EVAR, or thoracoabdominal aortic aneurysm (Crawford I–IV) at the Medical University of Vienna are eligible.
✕Probably not a fit
People under 18, women with childbearing potential (premenopausal), or patients not treated at the enrolling center are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, unblinded trial at the Medical University of Vienna enrolling adults undergoing fenestrated endovascular aortic repair (FEVAR) and randomizing them to receive either the BeFlared FEVAR Stent Graft System or the GORE® VIABAHN® VBX balloon-expandable endoprosthesis as the bridging device. The primary outcomes are cumulative device time and target vessel instability assessed early, short-term, and at midterm follow-up. A secondary outcome is intraoperative target vessel technical success. Procedural performance and vessel-related outcomes will be compared between the two device groups.
Why it matters
Potential benefit: If successful, one device could shorten operative time and reduce target vessel complications, improving safety and recovery for people having FEVAR.
How similar studies have gone: Balloon-expandable stents like VBX have prior clinical use as FEVAR bridging devices, while randomized head-to-head data comparing VBX with the newer BeFlared system are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
Vienna, State of Vienna, Austria Recruiting
Study contacts
- Study coordinator: Wolf Hans Eilenberg, MD, PhD
- Email: wolf.eilenberg@meduniwien.ac.at
- Phone: +43 (0)1 40400-69560
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.