Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorW.L.Gore & Associates

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

400 Participants
are grouped into 3 trial groups

Locations

This trial has no locations

Sponsors and collaborators