GORE TBE Device for Aortic Lesion

(SSB 11-02 Trial)

Not currently recruiting at 40 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the GORE® TAG® Thoracic Branch Endoprosthesis, a device designed to treat issues with the main artery in the chest, specifically the aortic arch and descending thoracic aorta. The researchers aim to determine if this device is safe and effective for repairing various aortic lesions, including aneurysms (bulging of the artery) and other issues like dissections (tears) or injuries. Suitable candidates include those whose doctors recommend surgery for aortic problems requiring specific device placement. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future aortic treatments.

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 prior data suggests that the GORE® TAG® Thoracic Branch Endoprosthesis is safe for treating aortic lesions?

Research has shown that the GORE® TAG® Thoracic Branch Endoprosthesis is generally safe for treating aortic problems. Studies have found that it can address sudden aortic issues without increasing the risk of complications. In early trials, the device was used successfully, showing positive results in patients with specific types of aortic injuries.

However, placing the device in weak tissue poses a risk, potentially causing new tears or even a rupture in the aorta. While the device has proven effective and mostly safe, doctors must exercise caution regarding its placement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE® TAG® Thoracic Branch Endoprosthesis (TBE) is unique because it provides a specialized solution for managing complex aortic lesions, particularly in Zone 2 of the aorta. Unlike traditional open surgery, which is more invasive, the TBE device offers a minimally invasive approach, potentially reducing recovery time and surgical risks. Additionally, this device is designed to accommodate both aneurysms and non-aneurysmal conditions like dissections or traumatic injuries, making it versatile for a range of aortic issues. Researchers are excited about its potential to improve patient outcomes with a less invasive procedure and broader applicability.

What evidence suggests that the GORE® TAG® Thoracic Branch Endoprosthesis is effective for treating aortic lesions?

Research has shown that the GORE® TAG® Thoracic Branch Endoprosthesis effectively treats aortic problems. Studies have reported a 100% success rate for the device, indicating it resolves issues without major complications within 30 days. In this trial, participants will receive treatment with the device for conditions in a specific part of the aorta called zone 2. Early results suggest it effectively repairs injuries in this area. The device also has approval for use in different areas of the aortic arch, supporting its effectiveness. Overall, the GORE® TAG® device has proven effective for treating conditions like aneurysms and tears in the aorta. ^{1 2 4 5 6}

Who Is on the Research Team?

Himanshu Patel, MD

Principal Investigator

University of Michigan

Michael M Dake, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Subject is capable of complying with protocol requirements, including follow-up

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).

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

My aorta is infected.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10731599/

Early experience with the Gore TAG thoracic branch ... Technical success, with exclusion of pathology and left subclavian patency, was 100% without major complications within 30 days. Our early Gore TBE device ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0890509624000979

Initial Outcomes of the Gore TAG Thoracic Branch ... Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02777593

NCT02777593 | Evaluation of the GORE® TBE Device in ... 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 ...

4. goremedical.com goremedical.com/products/thoracic-branch-endoprosthesis

GORE ® TAG ® Thoracic Branch Endoprosthesis Approved across all aortic arch zones · Zones 0 and 1 approved · 98.6% · 7.8% · Zone 2 proven · 99.2% · 3.6% · Whether it's Zone 0, 1 or 2, consider TBE for your next ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(22)01642-1/fulltext

Outcomes of endovascular repair of aortic aneurysms with ... The primary objective of the study presented here was to determine whether the GORE TAG Thoracic Branch Endoprosthesis (TBE device; W. L. Gore & ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210032C.pdf

GORE® TAG® Thoracic Branch Endoprosthesis Landing the proximal end of the device in dissected tissue couldincrease the risk of damage to the septum and could lead to new septal tears, aortic rupture, ...