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

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 (TAMBE Device), to determine its safety and effectiveness in treating aortic diseases involving the visceral vessels (organs in the abdominal area). The goal is to confirm that the device performs well in real-life situations and that the training for its use is sufficient. Individuals already treated with the aortic part of this device for their aortic condition are suitable candidates for this trial. As an unphased trial, this study allows patients to contribute to important research that could enhance future treatments.

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 prior data suggests that the TAMBE Device is safe for treating thoracoabdominal aortic aneurysm?

Research has shown that the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, or TAMBE Device, has been tested for safety in treating complex aneurysms. In one study involving 102 patients, results after one year indicated that the treatment was generally well-tolerated, with most patients not experiencing serious side effects.

Another study examined the first 30 days after treatment and found positive results, with no major safety issues reported. These findings suggest that the TAMBE Device is a safe and effective option for individuals with certain types of aortic aneurysms, which are bulges in the wall of the aorta.

Overall, these results support the safety of the TAMBE Device in treating complex aortic conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, known as the TAMBE Device, is unique because it offers a minimally invasive approach to treating thoracoabdominal aortic aneurysms. Unlike traditional open surgery, which involves significant risks and lengthy recovery times, this device can be deployed through a catheter, making the procedure less invasive. Researchers are excited because it potentially reduces complications and recovery time, offering a safer and more efficient alternative for patients with this complex condition.

What evidence suggests that the TAMBE Device is effective for thoracoabdominal aortic aneurysm?

Research has shown that the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, known as the TAMBE Device, yields promising results for treating thoracoabdominal aortic aneurysms. In a study of 102 patients, positive outcomes were reported one year after treatment. Early results indicated a high success rate, with the device placed correctly and functioning as expected. No deaths related to the aneurysm occurred within the first 30 days after treatment. These findings suggest that the TAMBE Device effectively manages complex aneurysms with few early complications. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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. 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 ...

3. 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.

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) for the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis device includes the absence of longer-term clinical follow-up data (e.g., full 5-year follow ...

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.