GORE® EXCLUDER® TAMBE PAS

Full Clinical Trial Name

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Clinical Trial

  • Heart and Vascular
  • Surgery

Patient Type

Adult
Doctor(s) running this study
Benjamin M. Jackson, MD, MS
Location(s):
Call 610-402-9543
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Purpose

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.

Description

This study is a prospective, single-arm, multicenter post-market study designed to collect clinical outcomes data from participants who have been treated with the TAMBE Aortic Component at up to 60 U.S. sites. 

This study will enroll a minimum of 300 adult participants receiving the TAMBE Aortic Component during the endovascular repair of an aortic disease involving the visceral vessels. Participants will be evaluated post-implantation and additional follow-ups will be provided at each site for all participants enrolled-implanted for up to 10 years.

To Participate

Please contact the Network Office of Research and Innovation at 610-402-9543.

Learn more about the full clinical trial

Full description at clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Subjects 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 procedure.
  3. An Informed Consent Form signed by the participant or legal representative.

Doctor(s) running this study