GORE TBE Device for Aortic Lesion
(SSB 11-02 Trial)
What You Need to Know Before You Apply
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.
Is the GORE TBE Device generally safe for humans?
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.16789
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.13789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the GORE® TAG® Thoracic Branch Endoprosthesis for treatment of lesions in the aortic arch and descending thoracic aorta
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of primary endpoint success
What Are the Treatments Tested in This Trial?
Interventions
- GORE® TAG® Thoracic Branch Endoprosthesis
Find a Clinic Near You
Who Is Running the Clinical Trial?
W.L.Gore & Associates
Lead Sponsor
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