Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Key facts
- Who runs it
- W.L.Gore & Associates
- Where
- Malmö and Stockholm, SwedenSee the 2 sitesAlso in 9 other countries, 24 sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 400 people, planned
- Starts
- Dec 2026
- Expected to end
- Dec 2035
- Type of study
- Observational, 3 groups
- Record updated
- 23 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 take part
- Patient has a prior visceral artery stenting not associated with registry procedure
- 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 treated for acute or sub-acute dissection, <90 days from onset of symptoms
- Patient has a life expectancy < 1-year
- Patient is participating in an investigational study which may confound registry results, unless approved by Gore
Where in Sweden
Also in 9 other countries, 24 sites
- Skåne University HospitalMalmö, SwedenNo longer taking part
- Karolinska University HospitalStockholm, SwedenNo longer taking part
About the trial
What the trial wants to find out
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
The 3 groups in the trial
- 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).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.
- Record updated
- 23 October 2026