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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

NCT ID: NCT06578741

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2037-03-01

Brief Summary

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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

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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.

Conditions

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Abdominal Aortic Aneurysm Pararenal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type OTHER

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Intervention Type DEVICE

Treatment with the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with Pararenal Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms

Interventions

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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Treatment with the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with Pararenal Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford Hospital

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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AAA 24-01

Identifier Type: -

Identifier Source: org_study_id