Aortic AneurysmBeFabNCT07295145
Bentley Bridging Stent Graft Study
An observational study of Aortic Aneurysm, run by Bentley InnoMed GmbH.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- endovascular aortic repair (EVAR)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2031
- Phase
- Observational
- 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
Study population: Adult patients having complex abdominal aortic aneurysms
Who may be able to join
- Adult patients having complex abdominal aortic aneurysms suitable for an endovascular repair with a fenestrated and/or branched aortic endovascular graft in combination with one Bentley bridging stent graft per reno-visceral artery in accordance with the IFU of BeFlared, BeGraft or BeGraft Plus. Use of different products for different target vessels is allowed. Use of stents from other manufacturers for other reno-visceral arteries is allowed.
- Patient is capable and willing to sign the informed consent and agrees to fulfil follow-up requirements
- Patients ≥18 years of age at the time of consent
Who cannot join
- Patients with contraindications as listed in the IFUs
- Previous stenting of the target vessel
- Extension/relining of Bentley BSGs
- Prior EVAR procedure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: BeFab: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of Bentley Bridging Stent Graft Systems
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.
- Conditions
- Aortic Aneurysm
- Being tested
- endovascular aortic repair (EVAR)
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular aortic repair (EVAR)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention
Measured: 12 months post index procedure
Secondary outcomes (21)
Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention
Measured: 1 month, 24 months, 36 months, 48 months, and 60 months post index procedure
Procedure-related complications
Measured: during procedure, at discharge and 1 month and 12 months post index procedure
Bridging stent-related complications
Measured: 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
Measured: during procedure
Primary patency rate defined as uninterrupted patency with no occlusion
Measured: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Secondary patency rate
Measured: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from secondary procedures
Measured: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from bridging stent related endoleaks
Measured: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Post-procedure Major adverse event rate
Measured: 1 month post procedure
Freedom from aneurysm-related death
Measured: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from aortic aneurysm maximum diameter increase
Measured: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Device implantation time
Measured: during procedure
Total procedure time
Measured: during procedure
total patient radiation dose
Measured: during procedure
total time of fluoroscopy
Measured: during procedure
total volume of received contrast medium
Measured: during procedure
Patient blood loss
Measured: during the procedure
duration of ICU stay
Measured: 1 month post index procedure
duration of total hospital stay
Measured: 1 month and 12 months post index procedure
mortality rate at 30 days
Measured: 1 month post index procedure
Quality of life score
EQ5D
Measured: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bentley InnoMed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295145
- Sponsor's protocol ID
- PM08-01 BeFab
- Acronym
- BeFab
- Status last verified
- Oct 2025
- First submitted
- 3 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeFab: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of Bentley Bridging Stent Graft Systems
- ClinicalTrials.gov ID
- NCT07295145
- Acronym / sponsor ID
- BeFab / PM08-01 BeFab
- Conditions
- Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bentley InnoMed GmbHIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 19 Dec 2025 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients having complex abdominal aortic aneurysms
Key inclusion criteria (3 listed)
- Adult patients having complex abdominal aortic aneurysms suitable for an endovascular repair with a fenestrated and/or branched aortic endovascular graft in combination with one Bentley bridging stent graft per reno-visceral artery in accordance with the IFU of BeFlared, BeGraft or BeGraft Plus. Use of different products for different target vessels is allowed. Use of stents from other manufacturers for other reno-visceral arteries is allowed.
- Patient is capable and willing to sign the informed consent and agrees to fulfil follow-up requirements
- Patients ≥18 years of age at the time of consent
Key exclusion criteria (4 listed)
- Patients with contraindications as listed in the IFUs
- Previous stenting of the target vessel
- Extension/relining of Bentley BSGs
- Prior EVAR procedure
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 |
|---|---|---|
| endovascular aortic repair (EVAR)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. | Device | – |
Primary outcome
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
21 secondary outcomes
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
Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
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 19 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, run by Bentley InnoMed GmbH.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Richard A Griesbach, Dr (+49 7471 9999 117, r.griesbach@bentley.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 19 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.