TAMBE Device for Thoracoabdominal Aortic Aneurysm

Overseen By Megan Mitchell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Disqualifiers: Contraindications, Parallel grafting, Modifications

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Time of index procedure

300 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) treatment for thoracoabdominal aortic aneurysm?

The GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) has shown promising early results in treating complex aortic aneurysms, with studies highlighting its technical feasibility and potential as an off-the-shelf option for challenging cases. The device has been part of early feasibility studies and is undergoing trials for FDA approval, indicating its potential effectiveness in managing these conditions. ^{1 2 3 4 5}

Is the TAMBE Device for Thoracoabdominal Aortic Aneurysm safe for humans?

The TAMBE device has been evaluated in early feasibility studies, showing successful device placement and no aneurysm ruptures. Early major adverse events were similar to previous device versions and significantly lower than traditional open surgery, suggesting it is generally safe for human use. ^{1 2 3 5 6}

How is the TAMBE treatment different from other treatments for thoracoabdominal aortic aneurysm?

The TAMBE treatment is unique because it is an off-the-shelf device with four branches designed to fit a wide range of patients, allowing for quicker treatment of complex aortic aneurysms without the need for custom-made devices. This is particularly beneficial in emergency situations where time is critical. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with various types of aortic aneurysms, specifically those involving the visceral vessels. Participants must have been treated with the GORE® EXCLUDER® TAMBE Aortic Component and signed an informed consent form.

Inclusion Criteria

I have signed the Informed Consent Form.

I have been treated with the GORE® EXCLUDER® device for aortic disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) during the index procedure

Time of index procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Visits at 1 month, 6 months, 12 months, and annually thereafter

Treatment Details

Interventions

• GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Trial Overview The study evaluates real-world use of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in patients with aortic aneurysms to confirm its ongoing safety and effectiveness, as well as assessing training adequacy.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

References

1. United States pubmed.ncbi.nlm.nih.gov

Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Anatomic feasibility of the investigational GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE), off-the-shelf multibranched endograft for the treatment of pararenal and thoracoabdominal aortic aneurysms. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Gore thoracoabdominal branched endoprosthesis: early results and impressions. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Techniques and Limitations of Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) for Type 1A Endoleak After Failed Endovascular Aortic Repairs. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Endoluminal versus open treatment of descending thoracic aortic aneurysms. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical trial results of a modified gore excluder endograft: comparison with open repair and original device design. [2016]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Thoracoabdominal branched repositionable device for an urgent complex aortic aneurysm. [2014]