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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

NCT06578741 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-02-13

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Aortic Aneurysm
  • Pararenal Aortic Aneurysm
  • Thoracoabdominal Aortic Aneurysm

Interventions

DEVICE

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

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2027-06-01
Completion
2036-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06578741 on ClinicalTrials.gov