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NCT07480395
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Conditions: Complex Aortic Aneurysms, Thoracoabdominal Aneurysm, Fenestrated Endovascular Aortic Repair, Endovascular Aortic Repair, Abdominal Aorta Aneurism, Chronic Dissection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 400
Sponsor: W.L.Gore & Associates
Location: Medical University Innsbruck Innsbruck
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
Eligibility Criteria
Inclusion Criteria:
1. Informed Consent Form (ICF) is signed by Subject.
2. Age ≥ 18 years at time of informed consent signature.
3. Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
4. 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).
5. Patient is willing to adhere to the institutional standard of care follow-up.
Exclusion Criteria:
1. Patient has a prior visceral artery stenting not associated with registry procedure.
2. Patient treated for acute or sub-acute dissection, \
Source: ClinicalTrials.gov (NCT07480395). StuddyBuddy aggregates publicly available trial information.
