An observational study in Aortic Aneurysm, sponsored by Bentley InnoMed GmbH. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Bentley InnoMed GmbH · Observational
This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects for the use as bridging stent grafts in combination with fenestrated aortic endovascular grafts.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 117 observational studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →Bentley InnoMed GmbH is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients having complex abdominal aortic aneurysms
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The primary goal of EVAR is to bypass the aneurysm sac with the aortic endovascular graft. Through isolation of the aneurysm sac, the blood pressure on the affected aortic tissue is reduced. This prevents aneurysm growth, which is otherwise associated with an elevated risk of rupture. As the pressure on the aneurysm sac is minimized, the current risk of rupture is also mitigated. In case that arteries branch off from the aorta in the area of the aneurysm, or at the proximal and distal sealing zones of the endograft, complex EVAR approaches are employed, which include stenting of the aortic branches (mostly renal and visceral arteries, also called target vessels) in addition to implantation of an aortic endovascular graft. A distinction is made between different variants of complex EVAR procedures, which comprise fenestrated endovascular aneurysm repair (FEVAR), branched endovascular aneurysm repair (BEVAR) and hybrid approaches.
Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention
Time frame: 12 months post index procedure
Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention
Time frame: 1 month, 24 months, 36 months, 48 months, and 60 months post index procedure
Procedure-related complications
Time frame: during procedure, at discharge and 1 month and 12 months post index procedure
Bridging stent-related complications
Time frame: during procedure, and 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
technical success defined as correct positioning and deployment of bridging stent grafts
Time frame: during procedure
Primary patency rate defined as uninterrupted patency with no occlusion
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Secondary patency rate
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from secondary procedures
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from bridging stent related endoleaks
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Post-procedure Major adverse event rate
Time frame: 1 month post procedure
Freedom from aneurysm-related death
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from aortic aneurysm maximum diameter increase
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Device implantation time
Time frame: during procedure
Total procedure time
Time frame: during procedure
total patient radiation dose
Time frame: during procedure
total time of fluoroscopy
Time frame: during procedure
total volume of received contrast medium
Time frame: during procedure
Patient blood loss
Time frame: during the procedure
duration of ICU stay
Time frame: 1 month post index procedure
duration of total hospital stay
Time frame: 1 month and 12 months post index procedure
mortality rate at 30 days
Time frame: 1 month post index procedure
Quality of life score
EQ5D
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bentley InnoMed GmbH