No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
126 (estimated)
Sponsor
Medical University of Vienna · Other
Who this trial is looking for
This trial is looking for patients with specific types of aortic aneurysms who need repair. Participants will receive either the BeFlared or VBX device during their treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have signed a consent form to join the study.
I understand what the study involves.
I have a juxtarenal, pararenal, or paravisceral abdominal aortic aneurysm.
I have had a previous endovascular aneurysm repair or I have a type of thoracoabdominal aortic aneurysm.
I am undergoing emergency or elective treatment with fenestrated endograft.
You may not be able to join if
I am under 18 years old.
I am pregnant or could become pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 v…
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.
Trial Locations
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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 …
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)
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