GORE EXCLUDER Device for Aortic Aneurysm

(TAMBE Trial)

Recruiting at 44 trial locations

Overseen By Sarah Rosbach

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Disqualifiers: Prior aortic surgery, Ruptured aneurysm, Myocardial infarction, Drug abuse, others

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

Compensation: Varies

Number of Visits: 1

102 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis treatment for aortic aneurysms?

The GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis has shown promising 30-day outcomes in an early feasibility study for treating certain types of aortic aneurysms, and similar devices from the same manufacturer have demonstrated long-term effectiveness in treating other types of aortic aneurysms. ^{1 2 3 4 5}

Is the GORE EXCLUDER Device for Aortic Aneurysm safe for humans?

The GORE EXCLUDER Device has been studied for safety in treating different types of aortic aneurysms. A study on the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis reported 30-day outcomes, and another study evaluated the long-term safety of the GORE EXCLUDER AAA Endoprosthesis for infrarenal aortic aneurysms, suggesting it is generally safe for human use. ^{1 2 3 6 7}

How is the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis treatment different from other treatments for aortic aneurysms?

The GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is unique because it is an off-the-shelf multibranched endograft specifically designed to treat complex aortic aneurysms, such as pararenal and thoracoabdominal aortic aneurysms, by allowing for precise positioning and improved sealing in challenging anatomical areas. ^{1 2 3 7 8}

Research Team

Mark Farber, MD

Principal Investigator

University of North Carolina

Eligibility Criteria

This trial is for adults over 19 with aortic aneurysms involving visceral vessels, who have suitable anatomy for the GORE EXCLUDER device. Candidates must not have had certain prior surgeries, infections, or conditions that would complicate the procedure or reduce life expectancy to under two years.

Inclusion Criteria

My aortic aneurysm extends close to my celiac artery and affects my abdominal aorta and at least one major artery.

I am 19 years old or older.

My aorta and related arteries fit the required sizes and conditions for the TAMBE Device.

Exclusion Criteria

I have an infection that could risk a graft infection.

You are not expected to live for more than 2 years.

My kidney function is impaired, indicated by high creatinine, low GFR, or I am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Index Procedure

Participants undergo the index procedure involving the implantation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for procedural safety and technical success

59 days

Multiple visits (in-person)

Extended Follow-up

Participants are monitored for clinically significant reinterventions and other outcomes

12 months

Regular visits (in-person)

Continued Access Phase

Additional subjects may be implanted under the Primary Study Arm

Treatment Details

Interventions

• GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Trial Overview The study tests the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in treating thoracoabdominal and pararenal aortic aneurysms. It's non-randomized with two arms: one focusing on just the TAMBE System and another combining it with CTAG Devices.

Participant Groups

Group I: Secondary Study Arm Experimental Treatment 1 Intervention

TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)

Group II: Primary Study Arm Active Control 1 Intervention

TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)

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

Findings from Research

The GORE EXCLUDER Conformable AAA Endoprosthesis has been successfully implanted in humans, addressing challenges in endovascular repair for abdominal aortic aneurysms, particularly in patients with short or highly angulated necks.

This innovative device offers features like repositionability and optional angulation control, which may enhance the accuracy of placement and improve long-term outcomes compared to previous generations of endografts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial human experience with the GORE EXCLUDER Conformable AAA Endoprosthesis. Rhee, R., Peterson, B., Moore, E., et al.[2020]

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

Long-Term Outcome of the GORE EXCLUDER AAA Endoprosthesis for Treatment of Infrarenal Aortic Aneurysms. [2017]

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

Successful off-label use of the GORE EXCLUDER Iliac Branch Endoprosthesis to preserve gluteal perfusion during staged endovascular repair of bilateral isolated hypogastric aneurysms. [2020]

5. England pubmed.ncbi.nlm.nih.gov

One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms. [2021]

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

Evaluation of the redesigned conformable GORE TAG thoracic endoprosthesis for traumatic aortic transection. [2013]

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

Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis. [2018]

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

Initial human experience with the GORE EXCLUDER Conformable AAA Endoprosthesis. [2020]