Abdominal Aortic AneurysmEMBRACENCT05143138
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
An observational study of Abdominal Aortic Aneurysm and Thoracic Aortic Aneurysm, run by W.L.Gore & Associates at 14 sites in 6 countries.
Trial summary
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
- What is being tested?
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 259 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 23 Mar 2022to Mar 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The registry has been designed with broad eligibility criteria to capture real-world data about GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis used as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair. Patients will be identified from hospital database.
Who may be able to join
- Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017
- Age ≥18 years at the time of implant
- Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations.
Who cannot join
- Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure
- Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
- Patient treated using physician-modified endovascular grafts
- Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan
- At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment
- Patient was pregnant at the time of treatment.
- Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints.
- Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Italy4 sites
IRCCS Ospedale Policlinico San Martino
Genova, 16132
"Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele
Milan, 20132
Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata
Roma, 00184
Azienda Ospedaliera Universitaria Policlinico Umberto I
Roma
Norway3 sites
Haukeland Universitetssjukehus
Bergen, 5021
UNN Tromsø
Tromsø, 9038
St. Olavs Hospital
Trondheim
Spain2 sites
Hospital Clínico Universitario San Cecilio
Granada, 18016
Hospital Clinico San Carlos
Madrid, 28040
Sweden2 sites
Skane University Hospital
Malmö, 214 28
Uppsala University Hospital
Uppsala, S-751 85
About this study
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
Read the detailed description
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
The registry procedures consist of two phases, retrospective phase and prospective phase.
The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature).
The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.
- Being tested
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisDevice
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
| Study group | Role | What they receive |
|---|---|---|
| fEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair Receives: Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | |
| bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair Receives: Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | |
| fEVAR and bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair Receives: Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Target Vessel Patency
Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start23 Mar 2022
- Primary completion30 Apr 2024
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 259 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca Bertoglio, Prof, Principal investigator, spedali civili brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143138
- Sponsor's protocol ID
- VBX 21-04
- Acronym
- EMBRACE
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2021
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Jonsdottir F, Bertoglio L, Resch T; EMBRACE Investigators. Three-Year Outcome of VBX Stent Graft Used as a Bridging Stent in Endovascular Repair of Post-Dissection Thorachoabdominal Aortic Aneurysm. J Cardiovasc Dev Dis. 2026 Jul 6;13(7):311. doi: 10.3390/jcdd13070311.
PubMed 42505888Dioni P, Wanhainen A, Budtz-Lilly J, Dias N, Bonny T, Bertoglio L; EMBRACE study investigator. GORE VIABAHN VBX Balloon-Expandable Endoprostheses as a Bridging Stent With Branched and Fenestrated Endografts in the Endovascular Treatment of Aortic Aneurysms: Protocol for a Retrospective Multicenter Registry (EMBRACE Study). JMIR Res Protoc. 2026 Feb 27;15:e78970. doi: 10.2196/78970.
PubMed 41773696
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
- ClinicalTrials.gov ID
- NCT05143138
- Acronym / sponsor ID
- EMBRACE / VBX 21-04
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 259 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
Detailed description
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
The registry procedures consist of two phases, retrospective phase and prospective phase.
The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature).
The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fEVAR | – | Device: GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisPatients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair |
| bEVAR | – | Device: GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisPatients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair |
| fEVAR and bEVAR | – | Device: GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisPatients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry has been designed with broad eligibility criteria to capture real-world data about GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis used as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair. Patients will be identified from hospital database.
Key inclusion criteria (3 listed)
- Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017
- Age ≥18 years at the time of implant
- Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations.
Key exclusion criteria (8 listed)
- Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure
- Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
- Patient treated using physician-modified endovascular grafts
- Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan
- At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment
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 |
|---|---|---|
| GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisPatients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent | Device | bEVAR, fEVAR, fEVAR and bEVAR |
Primary outcome
Number of Participants With Target Vessel Patency
Time frame: 12 months
Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42505888Jonsdottir F, Bertoglio L, Resch T; EMBRACE Investigators. Three-Year Outcome of VBX Stent Graft Used as a Bridging Stent in Endovascular Repair of Post-Dissection Thorachoabdominal Aortic Aneurysm. J Cardiovasc Dev Dis. 2026 Jul 6;13(7):311. doi: 10.3390/jcdd13070311.
- Derived from this study: PubMed 41773696Dioni P, Wanhainen A, Budtz-Lilly J, Dias N, Bonny T, Bertoglio L; EMBRACE study investigator. GORE VIABAHN VBX Balloon-Expandable Endoprostheses as a Bridging Stent With Branched and Fenestrated Endografts in the Endovascular Treatment of Aortic Aneurysms: Protocol for a Retrospective Multicenter Registry (EMBRACE Study). JMIR Res Protoc. 2026 Feb 27;15:e78970. doi: 10.2196/78970.
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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. This study is not recruiting at the moment.
Luca Bertoglio, Prof principal investigator
spedali civili brescia
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Thoracic Aortic Aneurysm, run by W.L.Gore & Associates at 14 sites in 6 countries.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, Norway, Denmark, Spain, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Target Vessel Patency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05143138, which also lists 2 linked publications.
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 21 Sep 2026.