Thoracic Branch Endoprosthesis for Aortic Lesions

(SSB 11-02 Trial)

Not currently recruiting at 42 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the GORE® TAG® Thoracic Branch Endoprosthesis, to determine its safety and effectiveness in treating aortic issues such as aneurysms or other lesions. The study focuses on the aortic arch and the descending thoracic aorta. Candidates for this trial have thoracic aortic issues requiring surgery and are considered high-risk for traditional open surgery.

As an unphased trial, it provides patients with access to innovative treatment options not yet widely available.

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 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 well-tolerated. Studies have found that this device, used to treat problems in the aortic arch, has been safely used in similar conditions. One study reported a success rate of over 98% in certain parts of the aorta, with only a small number of patients experiencing complications.

However, placing the device in weakened tissue carries a slight risk of damage, potentially leading to serious issues like a tear or rupture. Prospective participants should consider these potential risks and discuss them with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE® TAG® Thoracic Branch Endoprosthesis stands out because it offers a minimally invasive option for treating complex aortic lesions, like aneurysms and dissections, which typically require open surgery. Unlike traditional grafts, this endoprosthesis is designed to accommodate the unique anatomy of the thoracic aorta, potentially reducing recovery times and surgical complications. Researchers are excited because it could offer a safer, more efficient way to manage these serious conditions, improving patient outcomes compared to existing surgical methods.

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

Studies have shown that the GORE® TAG® Thoracic Branch Endoprosthesis effectively treats issues in the aortic arch and descending thoracic aorta. In this trial, participants will receive treatment for either Zone 0/1 Aortic aneurysms or Zone 0/1 Non-aneurysm aortic lesions using this device. Research indicates that early use of this device significantly lowers the risk of serious complications, such as aortic ruptures and loss of leg movement. One study found that during the first 30 days, there were no cases of aortic ruptures, complete loss of leg movement, or partial leg paralysis. However, there were small percentages of deaths related to the lesions (3.9%), strokes (7.8%), and blood leaks (6.0%). Overall, these results suggest the device is promising for safely managing aortic conditions. ^{3 4 6 7 8}

Who Is on the Research Team?

Himanshu Patel, MD

Principal Investigator

University of Michigan

Michael Dake, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

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 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.

How Is the Trial Designed?

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0741521425015551

Early Outcomes of Endovascular Repair of Aortic Arch ... The pivotal trial 30-day outcomes of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) in patients with endovascular repair of the aortic arch ...

2. 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 ...

3. annalsofvascularsurgery.com annalsofvascularsurgery.com/article/S0890-5096(24)00097-9/fulltext

Initial Outcomes of the Gore TAG Thoracic Branch ... Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention.

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

Early experience with the Gore TAG thoracic branch ... Our early Gore TBE device experience demonstrates safe use in acute aortic pathology without an increased risk of complications.

5. jvascsurg.org jvascsurg.org/article/S0741-5214(25)01555-1/fulltext

Early outcomes of endovascular repair of aortic arch ... The 30-day outcomes included no aortic ruptures, paraplegia, or paraparesis, 3.9% lesion-related deaths, 7.8% strokes, and 6.0% type I/III endoleak. •. Take ...

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

GORE ® TAG ® 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 ...

7. 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 ...

8. 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, ...