Thoracic Branch Endoprosthesis for Aortic Lesions

(SSB 11-02 Trial)

Recruiting at 39 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, Heparin

Disqualifiers: Stroke, Renal failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have known sensitivities or contraindications 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 Endoprosthesis has been shown to be effective and safe for treating thoracic aortic aneurysms, with advantages over open surgery, such as improved survival related to the aneurysm and similar overall survival rates. It has also been approved for other thoracic aortic conditions, showing progress in minimally invasive treatments for complex aortic issues. ^{1 2 3 4 5}

Is the GORE TAG Thoracic Branch Endoprosthesis safe for humans?

The GORE TAG Thoracic Endoprosthesis has been used safely in humans for various conditions, including thoracic aortic aneurysms and traumatic aortic injuries, since its FDA approval in 2005. Studies have shown it to be a safe alternative to open surgery for these conditions. ^{1 3 5 6 7}

How is the GORE® TAG® Thoracic Branch Endoprosthesis treatment different from other treatments for aortic lesions?

The GORE® TAG® Thoracic Branch Endoprosthesis is unique because it offers a minimally invasive alternative to open surgery for treating thoracic aortic lesions, making it suitable for patients who cannot undergo traditional surgery due to other health issues. Its design allows for flexibility and conformability, improving outcomes for complex aortic conditions. ^{1 3 4 5 8}

Research Team

Himanshu Patel, MD

Principal Investigator

University of Michigan

Michael Dake, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 with aortic arch or descending thoracic aorta lesions needing surgical repair, who can follow the study plan and have signed consent. It's not for those with recent heart attacks, drug abuse history, allergies to device materials, certain blood conditions, recent surgeries (except specific aortic procedures), pregnancy, participation in other trials within a year, poor imaging due to body habitus, high stroke risk or life expectancy under 2 years.

Inclusion Criteria

My aorta is suitable for surgery near the aneurysm.

Informed Consent Form (ICF) is signed by Subject or legal representative

Your blood vessels must be the right size and in the right place for the treatment to work.

Exclusion Criteria

I have not had a stroke in the last 6 weeks.

I need surgery for an aneurysm in my chest or abdomen.

I have not had any surgery in the last 30 days, except for specific heart or vascular access procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the endovascular procedure with the GORE® TAG® Thoracic Branch Endoprosthesis

12 months

Follow-up

Participants are monitored for safety and effectiveness after the procedure

12 months

Treatment Details

Interventions

• GORE® TAG® Thoracic Branch Endoprosthesis

Trial Overview The GORE® TAG® Thoracic Branch Endoprosthesis is being tested for safety and effectiveness in treating lesions of the aortic arch and descending thoracic aorta. The procedure involves placing this endoprosthesis within the affected area of the artery to support it.

Participant Groups

Group I: Zone 0/1 Non-aneurysm aortic lesions Experimental Treatment 2 Interventions

Includes dissection and other isolated lesion types

Group II: Zone 0/1 Aortic aneurysm Experimental Treatment 2 Interventions

Zone 0/1 Aortic aneurysm

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

Conformable GORE TAG thoracic endoprosthesis. [2014]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Midterm outcome in 158 consecutive Gore TAG thoracic endoprostheses: single center experience. [2022]