Active, currently enrolling
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
NCT No.: NCT06578741
Study Type: Clinical Trial
Phase:
n/a
Region: California - Northern
Acronym: AAA 24-01
Official Title
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Purpose
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.
Detailed Description
Eligibility Criteria
Inclusion Criteria
- The subject is / has:
1. Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
2. Age =18 years at the time of informed consent signature.
3. An Informed Consent Form signed by subject or legal representative.
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Exclusion Criteria
- The subject is / has:
1. Any contraindications for the TAMBE Device according to the IFU.
2. Planned parallel grafting with the TAMBE Aortic Component.
3. Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).
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Keywords and/or Specific Medical Conditions
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- Endoprosthesis,
Vascular Diseases,
Cardiovascular Diseases,
Aortic Diseases,
Aneurysm,
Aortic Aneurysm,
Aortic Aneurysm, Abdominal,
Aortic Aneurysm, Thoracoabdominal,
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Sponsors
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