GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

Study of an Endovascular Device for Aortic Disease

R
Raghu Motaganahalli, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
2 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential subjects will be identified by the research coordinator by EMR review or by the investigator in the IUH Vascular Surgery Clinic. Patients who have known Thoracoabdominal or Pararenal Aortic Aneurysms and who are being followed by Vascular Surgery for surveillance or patients who have a newly diagnosed Thoracoabdominal or Pararenal Aortic Aneurysm and are a new referral to clinic, will come to clinic. The physician will discuss the study with the patient. All potential subjects that meet inclusion criteria and do not meet exclusion criteria will be approached for potential participation.

Detailed description of study

This study is prospective, single-arm, multicenter post-market study designed to collect clinical outcomes data from subjects who have been treated with the TAMBE Aortic Component at up to sixty (60) clinical investigative sites (referred to as “sites” for the
remainder of the document) in the United States (U.S.).

This study will enroll a minimum of 300 subjects receiving the TAMBE Aortic Component during the endovascular repair of an aortic disease involving the visceral vessels. 

Subjects will be evaluated post-implantation and will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.
 

A minimum of 100 surviving subjects with evidence of continued study participation will be available at 5 years

 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Abdominal Aortic Aneurysm
  • Age: 18 years - 100 years
  • Gender: All

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).

Updated on 04 Aug 2025. Study ID: SURG-GORE-TAMBE-PAS, 24921

This study investigates the use of an endovascular device for treating aortic disease involving the visceral vessels. Aortic disease can affect the large blood vessel that carries blood from the heart to the rest of the body. The purpose of this study is to ensure the device's safety and effectiveness in a real-world setting.

Participants who receive the device will be evaluated after the procedure and followed up at regular intervals. This includes visits at 1 month, 6 months, 12 months, and yearly up to 10 years after the device is implanted. The study will gather data from multiple locations across the United States.

  • Who can participate: Adults aged 18 and over who have been treated with the endovascular device for aortic disease involving the visceral vessels may participate. Participants must have signed an informed consent form.
  • Study details: Participants will receive the endovascular device as part of their treatment for aortic disease. They will be monitored over time to collect data on the device's performance and safety.
  • Study timelines and visits: The study will last 10 years. The study requires 5 visits.
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only