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Real-world use of GORE stent grafts for complex aortic aneurysms

Collects real-world data on GORE devices repairing aortic aneurysms involving organ arteries.

Key facts

Who runs it
W.L.Gore & Associates
Where
Bologna, Brescia, Ferrara, Padova, and Roma, ItalySee the 5 sitesAlso in 9 other countries, 21 sites
Trial code
Registry title
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
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

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a complex aortic aneurysm (a bulge in the main body artery) that can be repaired from inside the artery. The repair must use at least 1 GORE VIABAHN VBX stent to keep blood flowing to gut or kidney arteries.

Age
18 years and older
Sex
All sexes
Disease stage
A thoracoabdominal, pararenal, juxtarenal or short-neck infrarenal aortic problem that can be repaired from inside the artery. At least 1 gut or kidney artery must be included in the repair (up to 6).
Earlier treatment
People who already had a stent in a gut or kidney artery outside this procedure cannot join.

Main reasons for not taking part

  • Treatment for a sudden or recent aortic tear (dissection), less than 90 days from first symptoms
  • Planned repair with parallel graft (chimney, periscope, sandwich) or octopus technique
  • Allergy to heparin or past heparin-induced low platelets (HIT type II)
  • Blood clotting disorders that cannot be treated
  • Expected to live less than 1-year

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 Italy

Also in 9 other countries, 21 sites

  • Policlinico di Sant'OrsolaBologna, ItalyNo longer taking part
  • ASST Spedali Civili di BresciaBrescia, ItalyNo longer taking part
  • Arcispedale Sant'AnnaFerrara, ItalyNo longer taking part
  • AOU PadovaPadova, ItalyNo longer taking part
  • AOU Policlinico Umberto IRoma, ItalyNo 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

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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.
Plain-language title
Real-world use of GORE stent grafts for complex aortic aneurysmsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
23 October 2026