GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

W.L. Gore & Associates

Status: Invitation-only

Conditions: Pararenal Aortic Aneurysm; Abdominal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Treatments: Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06578741

AAA 24-01

Details and patient eligibility

About

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.

Full description

A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Single Arm

Other group

Description:

Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Treatment:

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)