Complex Aortic AneurysmsENVISIONNCT07480395
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
An observational study of Complex Aortic Aneurysms and Thoracoabdominal Aneurysm, run by W.L.Gore & Associates at 26 sites in 10 countries.
Trial summary
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Aortic Aneurysms, Thoracoabdominal Aneurysm, Fenestrated Endovascular Aortic Repair
- How many people
- 400 participants
- Where
- 26 sitesin 10 countries
- Study dates
- Dec 2026to Dec 2035
- How long will I take part?
- 5 Years
- 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: The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion. Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set.
Who may be able to join
- Informed Consent Form (ICF) is signed by Subject.
- Age ≥ 18 years at time of informed consent signature.
- Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
- Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).
- Patient is willing to adhere to the institutional standard of care follow-up.
Who cannot join
- Patient has a prior visceral artery stenting not associated with registry procedure.
- Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
- Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.
- Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- Patient has known coagulation disorders including hypercoagulability that are not amenable to treatment.
- Patient has a life expectancy < 1-year.
- Patient is participating in an investigational study which may confound registry results, unless approved by Gore
Trial locations and contacts
26 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 10 countries
Germany5 sites
Universitäts-Herzzentrum Bad Krozingen
Bad Krozingen
University Medical Center Hamburg-Eppendorf
Hamburg
University of Heidelberg
Heidelberg
Helios Hospital München West
München
LMU Klinikum Campus Großhadern
München
Italy5 sites
Policlinico di Sant'Orsola
Bologna
ASST Spedali Civili di Brescia
Brescia
Arcispedale Sant'Anna
Ferrara
AOU Padova
Padova
AOU Policlinico Umberto I
Roma
United Kingdom3 sites
University Hospital Birmingham
Birmingham
St Thomas Hospital
London
Manchester Royal Infirmary
Manchester
Austria2 sites
Medical University Innsbruck
Innsbruck
Medizinische Universität Wien
Vienna
Greece2 sites
Laiko General Hospital of Athens
Athens
Larissa University Hospital
Larissa
Netherlands2 sites
Amsterdam UMC
Amsterdam
Elisabeth-Tweesteden Hospital
Tilburg
Spain2 sites
Complejo Hospitalario Universitario de La Coruña
A Coruña
Hospital Clinico San Carlos
Madrid
Sweden2 sites
Skåne University Hospital
Malmö
Karolinska University Hospital
Stockholm
Switzerland2 sites
University Hospital Basel
Basel
University Hospital Bern
Bern
About this study
Official title: The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion
Read the detailed description
Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set
- Conditions
- Complex Aortic Aneurysms, Thoracoabdominal Aneurysm, Fenestrated Endovascular Aortic Repair, Endovascular Aortic Repair, Abdominal Aorta Aneurism, Chronic Dissection
- Keywords
- FEVAR, BEVAR, TAAA, AAA, Visceral, aortic aneurysm, PMEGs
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FEVAR | Patients who are treated with aortic endografts designed exclusively with fenestrations for incorporation of the visceral arteries with at least one BXB device implanted | |
| BEVAR | Patients who are treated with aortic endografts designed exclusively with directional branches for incorporation of the visceral arteries with at least one BXB device implanted | |
| OTHER | Patients who are treated with other endovascular techniques who required incorporation of BXB as bridging stent (i.e. PMEGs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Target Vessel Instability
Freedom from any death or rupture related to side branch complication (e.g., endoleaks, rupture); any branch occlusion; or any secondary intervention indicated to treat a branch-related complication, including endoleaks, disconnection, kink, stenosis, occlusion, or rupture
Measured: through 1 year Follow-up
Secondary outcomes (12)
Target Vessel Technical Success
Successful catheterization and stent placement in all intended target vessels.
Measured: At procedure
Procedural Technical Success
All of the qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleak, branch occlusion, or graft limb obstruction):
- Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits at index procedure.
- Successful delivery and deployment of the aortic stent graft and all modular stent graft components at index procedure
- Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels at final completion angiography
- Absence of type I or type III endoleaks at final completion angiography that extends beyond 30 days by confirmatory imaging
- Patency of all aortic modular stent graft components and intended side branch components at final completion angiography.
Measured: at procedure
Clinical Success
Requires all of the following to be met:
- Procedural Technical success
- Absence of death from the initial procedure, secondary intervention, or aorta-related cause
- Absence of persistent type I or type III endoleaks
- Absence of aneurysm sac expansion > 5mm
- Absence of device migration > 10mm
- Absence of failure due to device integrity issues
- Absence of aneurysm rupture
- Absence of conversion to open surgical repair
- Absence of permanent paraplegia
- Note: defined as spinal cord deficit with inability to walk and not resolving at a future assessment
- Absence of disabling stroke
- Note: defined as stroke with one of the following: complete hemianopia, severe aphasia, visual or sensory extinction, or any weakness limiting sustained effort against gravity
- Absence of new-onset dialysis following the initial operation
Measured: through 5-year follow-up
Major Adverse Events
Any of the following events:
- All-cause mortality
- Myocardial infarction (MI): MI resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome
- Respiratory failure requiring prolonged (> 24 hours from anticipated) mechanical ventilation or reintubation
- Renal function decline characterized by one or more of the following:
- >50% reduction in baseline estimated glomerular filtration rate (eGFR); or,
- New-onset dialysis
- Bowel ischemia requiring surgical resection or not resolving with medical therapy
- Permanent paraplegia
- Major stroke.
- Note: any stroke that is disabling or fatal
Measured: through 5-year follow-up
Freedom from Aneurysm-Related Mortality
Freedom from all the following:
- Any death that occurs within the first 30 days
- any death that results from aneurysm rupture, aorta-related complications such as infection, occlusion, dissection, hematoma, or
- any death that results from a complication of a secondary intervention
Measured: through 5-year follow-up
Freedom from Target Vessel Instability through 5-year follow-up
Freedom from any death or rupture related to side branch complication (e.g., endoleaks, rupture); any branch occlusion; or any secondary intervention indicated to treat a branch-related complication, including endoleaks, disconnection, kink, stenosis, occlusion, or rupture
Measured: through 5-year follow-up
Primary Patency
Uninterrupted patency with no occlusion or additional procedures performed intended to maintain patency of the stent or native target vessel.
Note: Interventions intended to treat endoleaks or stent disconnection do not count as loss of primary patency.
Measured: through 5-year follow-up
Freedom from Reintervention
Any repeated vascular or nonvascular procedure on the aortic endovascular stent graft, its branches, or any other stent graft placed in combination with these devices during the index procedure.
Measured: through 5-year follow-up
Survival
Freedom from all-cause mortality
Measured: through 5-year follow-up
Aneurysm sac changes
Aneurysm Enlargement: An increase in maximum aorta diameter of > 5mm in the region encompassed by the initial aneurysm as compared to baseline.
Aneurysm Shrinkage: A decrease in aorta diameter of > 5-mm in the region encompassed by the initial aneurysm as compared to baseline.
Stable Aneurysm: A ≤ 5 millimeter (mm) change in aorta diameter in the region encompassed by the initial aneurysm as compared to baseline.
Measured: through 5-year follow-up
Primary Assisted Patency
Number of patients with endovascular intervention performed to maintain patency in the presence of a stenosis before occlusion
Measured: through 5-year follow-up
Secondary Patency
Number of patients with endovascular restoration of patency after occlusion of the side branch, stent, or stent graft has already occurred.
Measured: through 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Aortic AneurysmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480395
- Sponsor's protocol ID
- VSC 25-08
- Acronym
- ENVISION
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 23 Oct 2026
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.
- ClinicalTrials.gov ID
- NCT07480395
- Acronym / sponsor ID
- ENVISION / VSC 25-08
- Conditions
- Complex Aortic Aneurysms, Thoracoabdominal Aneurysm, Fenestrated Endovascular Aortic Repair, Endovascular Aortic Repair, Abdominal Aorta Aneurism, Chronic Dissection
- Keywords
- FEVAR, BEVAR, TAAA, AAA, Visceral, aortic aneurysm, PMEGs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 18 Mar 2026 (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.
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion
Detailed description
Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FEVAR | – | –Patients who are treated with aortic endografts designed exclusively with fenestrations for incorporation of the visceral arteries with at least one BXB device implanted |
| BEVAR | – | –Patients who are treated with aortic endografts designed exclusively with directional branches for incorporation of the visceral arteries with at least one BXB device implanted |
| OTHER | – | –Patients who are treated with other endovascular techniques who required incorporation of BXB as bridging stent (i.e. PMEGs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion. Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set.
Key inclusion criteria (5 listed)
- Informed Consent Form (ICF) is signed by Subject.
- Age ≥ 18 years at time of informed consent signature.
- Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
- Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).
- Patient is willing to adhere to the institutional standard of care follow-up.
Key exclusion criteria (7 listed)
- Patient has a prior visceral artery stenting not associated with registry procedure.
- Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
- Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.
- Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- Patient has known coagulation disorders including hypercoagulability that are 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.
Primary outcome
Freedom from Target Vessel Instability
Time frame: through 1 year Follow-up
Freedom from any death or rupture related to side branch complication (e.g., endoleaks, rupture); any branch occlusion; or any secondary intervention indicated to treat a branch-related complication, including endoleaks, disconnection, kink, stenosis, occlusion, or rupture
12 secondary outcomes
Target Vessel Technical Success
Time frame: At procedure
Procedural Technical Success
Time frame: at procedure
Clinical Success
Time frame: through 5-year follow-up
Major Adverse Events
Time frame: through 5-year follow-up
Freedom from Aneurysm-Related Mortality
Time frame: through 5-year follow-up
Freedom from Target Vessel Instability through 5-year follow-up
Time frame: through 5-year follow-up
Primary Patency
Time frame: through 5-year follow-up
Freedom from Reintervention
Time frame: through 5-year follow-up
Survival
Time frame: through 5-year follow-up
Aneurysm sac changes
Time frame: through 5-year follow-up
Primary Assisted Patency
Time frame: through 5-year follow-up
Secondary Patency
Time frame: through 5-year follow-up
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 23 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Aortic Aneurysms and Thoracoabdominal Aneurysm, run by W.L.Gore & Associates at 26 sites in 10 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 5 inclusion and 7 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Italy, United Kingdom, Austria, Greece and 5 more countries. 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?
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?
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?
Freedom from Target Vessel Instability (time frame: through 1 year Follow-up). 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 23 Oct 2026.