GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Part of paid clinical trials in Stanford, California.

Sponsor
W.L.Gore & Associates
Study ID
NCT06578741
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 25, 2024
Status verified
Feb 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2036

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm
    Treatment with GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Primary Outcome Measure

Co-Primary Endpoint #1: Technical Success [ Time Frame: Time of index procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford HospitalStanfordCalifornia94305-

Find similar trials in Stanford, CA

By research site
Stanford Hospital· Stanford, CA

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