GORE TBE Device for Aortic Lesion

(SSB 11-02 Trial)

Recruiting at 38 trial locations

Overseen By Ashley Hoedt, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Aortic disease, Stroke, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-procedure

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you have known sensitivities or allergies to anticoagulants or contrast media, this may affect your eligibility.

What data supports the effectiveness of the GORE® TAG® Thoracic Branch Endoprosthesis treatment for aortic lesions?

The GORE® TAG® Thoracic Branch Endoprosthesis has been shown to be effective in treating thoracic aortic aneurysms, with studies indicating it has advantages over open surgical repair, such as improved aneurysm-related mortality. Additionally, it has been used successfully in other thoracic aortic diseases, demonstrating its versatility and effectiveness in similar conditions. ^{1 2 3 4 5}

Is the GORE TBE Device generally safe for humans?

The GORE TAG thoracic endoprosthesis has been shown to be safe in clinical trials for treating thoracic aortic aneurysms, with FDA approval since 2005. It has been used successfully in various thoracic aortic conditions, and studies suggest it is safer than open surgery. ^{1 3 6 7 8}

What makes the GORE TBE Device treatment unique for aortic lesions?

The GORE TBE Device is unique because it is the first off-the-shelf thoracic branch stent-graft approved for treating distal aortic arch lesions that require extension into zone 2, which helps avoid complications like arm ischemia and stroke by preserving blood flow to the left subclavian artery. ^{2 3 4 5 9}

Research Team

Himanshu Patel, MD

Principal Investigator

University of Michigan

Michael M Dake, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 with thoracic aortic lesions needing surgical repair, who can follow the study's requirements. They must have suitable areas in their aorta for device placement but no infections, recent drug abuse, or conditions like Marfan's Syndrome. Pregnant women and those with certain allergies or medical conditions that affect imaging quality are excluded.

Inclusion Criteria

My heart's main artery has a suitable area for treatment.

My aorta is suitable for surgery near the aneurysm.

I need surgery for a thoracic aortic issue requiring a graft in the upper chest area.

Exclusion Criteria

You have had a bad reaction to heparin in the past, or have a condition called Heparin Induced Thrombocytopenia type 2 (HIT-2).

My aorta is infected.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GORE® TAG® Thoracic Branch Endoprosthesis for treatment of lesions in the aortic arch and descending thoracic aorta

Immediate post-procedure

1 visit (in-person for procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of primary endpoint success

12 months

Treatment Details

Interventions

• GORE® TAG® Thoracic Branch Endoprosthesis

Trial Overview The GORE® TAG® Thoracic Branch Endoprosthesis is being tested to see if it's safe and effective for treating aortic arch and descending thoracic aorta lesions when implanted in Zone 2 of the aorta.

Participant Groups

Group I: Zone 2 Non-aneurysm Experimental Treatment 1 Intervention

Includes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.

Group II: Zone 2 Aneurysm Experimental Treatment 1 Intervention

Includes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.

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. Italy pubmed.ncbi.nlm.nih.gov

Practical experience with the TAG and conformable TAG devices: lessons learned in about 100 cases. [2016]

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

Physician Modification to Shorten a TAG Thoracic Endoprosthesis for Treatment of a Pseudoaneurysm in the Ascending Aorta. [2017]

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

Endovascular repair of the thoracic aorta in the post-FDA approval era. [2009]

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

Use of retrograde left subclavian branch portal of Gore TAG thoracic branch endoprosthesis for physician-modified fenestrated branched endovascular repair of thoracoabdominal aortic aneurysm. [2023]

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

Mid-term results of a multicenter study of thoracic endovascular aneurysm repair versus open repair. [2008]

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

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

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

"Real world" thoracic endografting: results with the Gore TAG device 2 years after U.S. FDA approval. [2022]

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

Endovascular therapy of thoracic aneurysms: Gore TAG trial results. [2007]

9. Italy pubmed.ncbi.nlm.nih.gov

Technical tips and clinical experience with the Gore Thoracic Branch Endoprosthesis®. [2023]