GORE EXCLUDER Device for Aortic Aneurysm

(TAMBE Trial)

Not currently recruiting at 46 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis, designed to treat aortic aneurysms—dangerous bulges in the main blood vessel leading from the heart. The study consists of two parts: one examines the device alone, and the other tests it with an additional component for specific aneurysm types. Suitable candidates have aortic aneurysms involving visceral vessels, are better suited for a less invasive procedure, and have not undergone previous open-heart surgeries. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research and potentially benefit from an innovative treatment option.

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 prior data suggests that the GORE EXCLUDER Device is safe for treating aortic aneurysms?

Research has shown that the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is a well-tolerated treatment for complex aneurysms. In one study with 102 patients, the treatment yielded positive results after one year. Another study confirmed the device's safe and effective use in patients with these specific aneurysms.

The FDA has already approved the device for treating complex aneurysmal disease, indicating it meets safety standards for human use in that condition.

Overall, these findings suggest the treatment is generally safe for those who need it, with no major safety concerns reported in the available studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis because it represents a significant advancement in the treatment of thoracoabdominal aortic aneurysms (TAAA). Unlike traditional open surgery, which is highly invasive and requires a lengthy recovery, this device offers a minimally invasive alternative, potentially reducing recovery time and complications. Additionally, the device is designed to accommodate the complex anatomy of TAAA, particularly for those classified as Crawford Type I-IV. This tailored approach could improve outcomes by ensuring better fit and function compared to one-size-fits-all solutions.

What evidence suggests that this trial's devices could be effective for aortic aneurysm?

Research has shown that the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) holds promise for treating aortic aneurysms. In this trial, participants in the Primary Study Arm will receive the TAMBE System alone, which has demonstrated success in treating extent IV thoracoabdominal aortic and pararenal aneurysms. One study found the treatment successful in most cases, with few complications and no aneurysm-related deaths in the first 30 days. After one year, patients with these aneurysms continued to do well. This suggests the device could be a reliable option for individuals with these complex conditions. ^{1 2 4 6 7}

Who Is on the Research Team?

Mark Farber, MD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0741521425010456

One-year outcomes from the pivotal trial of a four-branch off ... Key Findings: One-year outcomes of treatment in 102 patients with extent IV thoracoabdominal aortic and pararenal aneurysms using the GORE EXCLUDER ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03728985

Study Details | NCT03728985 | Evaluation of the GORE® ... Prospective, non-randomized, , multicenter study with two independent arms: Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230023B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) provides endovascular treatment of aneurysms extending into the visceral segment of the.

4. jvascsurg.org jvascsurg.org/article/S0741-5214(24)01199-6/fulltext

Early outcomes from the pivotal trial of a four-branch off ... This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38904579/

Early outcomes from the pivotal trial of a four-branch off- ... Conclusions: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety ...

6. goremedical.com goremedical.com/products/tambe

TAMBE: EXCLUDER® Thoracoabdominal Branch ... The first FDA-approved, off-the-shelf, endovascular repair solution for the treatment of complex aneurysmal disease involving the visceral aorta.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30612825/

Technical aspects and 30-day outcomes of the prospective ... This study confirms the early feasibility of the TAMBE for treatment of pararenal and extent IV thoracoabdominal aortic aneurysms.