BeFlared Versus VBX for FEVAR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Randomization.
- Who it may be relevant to
- Registry conditions: Fenestrated Endovascular Aortic Repair. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BeFlared FEVAR Stent Graft System© Versus GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for Fenestrated Endovascular Aortic Repair - Randomized Controlled Unblinded Clinical Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Cumulative device time [Time frame: Intraoperative assessment during recruitment period of 2 years]
- 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]
Secondary outcome measures (1)
- Intraoperative target vessel (TV) success [Time frame: Intraoperative assessment during recruitment period of 2 years]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Austria · 1 center
- Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery — Vienna
Identifiers
NCT: NCT07424885 · 1501/2025