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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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