AzTrials
AzTrials

Aortic Arch DissectionNCT07166133

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

A study testing GORE® TAG® Thoracic Branch Endoprosthesis in people with Aortic Arch Dissection and Aortic Arch Aneurysm, run by W.L.Gore & Associates at 22 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Arch Dissection, Aortic Arch Aneurysm
What is being tested?
GORE® TAG® Thoracic Branch Endoprosthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
22 sitesUnited States
Study dates
2 Mar 2026to Mar 2036
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
  • Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.
  • Patient is age ≥ 18 years at time of informed consent signature.

Who cannot join

  • Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
  • Patient with exclusion criteria required by local law.
  • Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study within 12 months of study enrollment. Subjects cannot be enrolled in another Gore study.

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

DeAnne Hart contact

800-437-8181

tbe25-03@wlgore.com

22 sites in 1 country

United States22 sites, 22 recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

    Shahab Toursavadkohi, MD, 410-328-5840, stoursavadkohi@som.umaryland.edu

    Shahab Toursavadkohi, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Mehrdad Ghoreishi, MD, 410-955-2800, mghorei1@jh.edu

    Mehrdad Ghoreishi, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Mark Farber, MD, 919-966-3391, mark_farber@med.unc.edu

    Mark Faber, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    G. Chad Hughes IV, MD, 919-668-0903, gchad.hughes@duke.edu

    G. Chad Hughes IV, MD

    Recruiting

  • University of Florida Health Heart & Vascular

    Gainesville, Florida, 32608

    Martin Back, MD, 352-273-5484, martin.back@surgery.ufl.edu

    Martin Back, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Akhilesh Jain, MD, 860-522-4158, akhilesh.jain@hhchealth.org

    Akhilesh Jain, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Steven Maximus, MD, 832-355-9571, steven.maximus@bcm.edu

    Steven Maximus, MD

    Recruiting

  • The Methodist Hospital-Houston

    Houston, Texas, 77030

    Marvin Atkins, MD, 713-441-5200, mdatkins@houstonmethodist.org

    Marvin Atkins, MD

    Recruiting

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

    Mohammed Hassan, MD, 863-413-5969, mohammed.hassan@mylrh.org

    Mohammed Hassan, MD

    Recruiting

  • Keck Medical Center of USC

    Los Angeles, California, 90033

    Sukgu Han, MD, 323-442-5849, sukgu.han@med.usc.edu

    Sukgu Han, MD

    Recruiting

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792

    Kyla Bennett, MD, 608-265-4420, bennettk@surgery.wisc.edu

    Kyla Bennett, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Peter Rossi, MD, 414-955-1800, prossi@mcw.edu

    Peter Rossi, MD

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Jane He, MD, 801-507-4700, jane.he@imail2.org

    Jane He, MD

    Recruiting

  • Stanford University Hospital and Clinics

    Palo Alto, California, 94304-5407

    A. Claire Watkins, MD, 650-723-5771, acwat@stanford.edu

    A. Claire Watkins, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Cecilia Chin, MD, 617-835-9038, cecillia.chin@jefferson.edu

    Cecilia Chin, MD

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Bart Chess, MD, 412-359-8820, bart.chess@ahn.org

    Bart Chess, MD

    Recruiting

  • Baylor Scott & White Research Institute

    Plano, Texas, 75093

    Justin Schaffer, MD, 469-800-6200, justin.schaffer@bswhealth.org

    Justin Schaffer, MD

    Recruiting

  • University of California Davis Health System

    Sacramento, California, 95817

    Andrew Barleben, MD, 916-734-6609, abarleben@health.ucdavis.edu

    Andrew Barleben, MD

    Recruiting

  • HonorHealth

    Scottsdale, Arizona, 85251

    Hasan Aldailami, MD, 480-246-3000, haldailami@honorhealth.com

    Hasan Aldailami, MD

    Recruiting

  • University of Washington Medical Center

    Seattle, Washington, 98195

    Matthew Sweet, MD, 206-598-8487, mpsweet@uw.edu

    Matthew Sweet, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Halim Yammine, MD, 813-821-8034, hyammine@usf.edu

    Halim Yammine, MD

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    William Yoon, MD, 202-877-5975, william.j.yoon@medstar.net

    William Yoon, MD

    Recruiting

Other trials in United States

About this study

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Read the detailed description

Minimum of 125 total subjects with a TBE Device implantation procedure initiated in up to 50 Sites in the United States. Subjects will have follow-up at 1 Month, 6 Month, 1 Year, and annually thereafter for a minimum of 5-years and up to a maximum of 10 years.

Being tested
GORE® TAG® Thoracic Branch Endoprosthesis
Keywords
Zone 0, Zone 1
Medical subject headings
Dissection, Thoracic Aorta, Aneurysm, Aortic Arch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE® TAG® Thoracic Branch EndoprosthesisDevice

    Lesions in aortic arch in Zone 0 or Zone 1

Study groups in NCT07166133
Study groupRoleWhat they receive
GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)OtherNot described
Receives: Device: GORE® TAG® Thoracic Branch Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure

    Great vessel surgical revascularization procedure is completed, and the endovascular implantation procedure is initiated for the implantation of the TBE Device, without interim death or study discontinuation.

    Measured: Index Endovascular Procedure Only

  2. Device Technical Success (index procedure only)

    • Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.
    • Patency of the endovascular aortic and side branch components.
    • The absence of any unanticipated additional corrective procedure related to the device, procedure, or withdrawal of the delivery system.

    Measured: Index Endovascular Procedure Only

  3. Lesion-related mortality

    Death meeting at least one of the following characteristics:

    • Death during the hospitalization or within 30 days following the surgical revascularization procedure.
    • Death during the hospitalization or within 30 days following the index endovascular procedure or following conversion to open repair.
    • Death during the hospitalization or within 30 days following a complication from a secondary procedure associated with the index lesion or study device.
    • Any death where the treated disease / index lesion or study device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion.

    Measured: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure

  4. Disabling Stroke

    Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that:

    • Is identified within 30-days following the surgical revascularization procedure or within 30-days following the index endovascular procedure -AND-
    • Persists for ≥ 24 hours or until death, or has symptoms lasting < 24 hours, with pathology or neuroimaging confirmation of CNS infarction -AND-
    • Has an mRS ≥ 2 with an increase from baseline of at least one grade due to neurological deficits at no more than 120 days post index endovascular procedure.

    Measured: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure

  5. Permanent Paraplegia (within 30-days)

    Paraplegia secondary to Spinal Cord Ischemia identified within 30 days following the index endovascular procedure combined with Spinal Cord Ischemia scale grade = 3 at the one-month follow-up visit. Paraplegia will be assessed using the SVS spinal cord ischemia grading system

    Measured: Within 30 days of index endovascular procedure

  6. Permanent Paraparesis (within 30-days)

    Paraparesis secondary to Spinal Cord Ischemia identified within 30 days following the index endovascular procedure, combined with Spinal Cord Ischemia scale grade = 2 at the one-month follow-up visit. Paraparesis will be assessed using the SVS spinal cord ischemia grading system.

    Measured: Within 30 days of index endovascular procedure

  7. New onset renal failure (within 30-days) requiring on-going dialysis

    New onset of sustained renal failure identified within 30 days following the index endovascular procedure, combined with requiring dialysis at the 1-Month follow-up visit.

    Measured: Within 30 days of index endovascular procedure

  8. Lesion rupture (treated area)

    Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.

    Measured: Minimum of 60 months and up to a maximum 120 months

  9. Loss of aortic or branch patency

    No flow or contrast detected through the implanted aortic component or endovascular branch component confirmed with imaging and/or direct observation.

    Measured: Minimum of 60 months and up to a maximum of 120 months

  10. Endoleaks

    Perfusion of a treated lesion via:

    • Type I endoleak is defined as a sealing failure at one of the attachment zones of the graft to the vessel wall, whereby arterial flow perfuses the treated lesion via a perigraft channel:
    • Type Ia: Proximal aortic attachment zone
    • Type Ib: Distal aortic attachment zone
    • Type Ic: Distal attachment zone for branch component.
    • Type II: Retrograde flow from native aortic branch arteries.
    • Type III endoleak: Component disconnection or fabric disruption resulting in arterial flow into the perigraft space:
    • Type IIIa: Attachment of aortic components (aortic-aortic)
    • Type IIIb: Fabric tear or disruption
    • Type IIIc: Attachment of aortic component-side-branch or side-branch-side-branch.
    • Type IV: Late endoleak due to flow through porous fabric.
    • Type V/Endotension: Aneurysm sac enlargement > 5 mm with no imaging evidence of an endoleak.
    • Indeterminate: Endoleak is identified, but source cannot be ascertained.

    Measured: Minimum of 60 months and up to a maximum of 120 months

  11. Reintervention

    Additional surgical or interventional procedure related to the treated disease / index lesion, the study device, or to the treatment / procedure.

    This may include surgical or interventional treatment for endoleaks, disease progression, procedures on the branch to improve or restore patency, spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery.

    Events will not include access site(s) complications, interventions to address issues related to non-treated area of the index lesion, such as bare stent implantation to address bowel ischemia associated with aortic dissection.

    Measured: Minimum of 60 months and up to a maximum of 120 months

Secondary outcomes (17)

  1. Access-related complications (index endovascular procedure only)

    Complications associated with the access sites used during treatment and any subsequent unplanned access-related reinterventions. This may include pseudoaneurysm, thrombosis, or complications associated with percutaneous closure devices.

    Measured: Index endovascular procedure only

  2. Life threatening bleed (index endovascular procedure only)

    An event associated with the index endovascular procedure leading to any of the following events as prior to discharge:

    • Overt bleeding requiring a transfusion of ≥5 units of whole blood/red blood cells within 48 hours of index endovascular procedure.
    • Cardiac tamponade
    • Overt bleeding requiring reoperation, surgical exploration, or reintervention for the purpose of controlling bleeding
    • Bleeding requiring intravenous vasoactive drugs
    • Fatal bleeding is bleeding that directly causes death with no other explainable cause

    Measured: Index endovascular procedure only

  3. Stroke

    Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that:

    • Persists for ≥ 24 hours or until death -OR-
    • Symptoms lasting < 24 hours, with pathology or neuroimaging confirmation of CNS infarction.

    Disabling stroke will be determined based on mRS ≥ 2 with an increase from baseline of at least one grade due to neurological deficits at no more than 120 days following the suspected stroke event.

    Measured: Minimum of 60 months and up to a maximum of 120 months

  4. Transient Ischemic Attack (TIA)

    Transient focal neurological signs or symptoms (lasting < 24 h) presumed to be due to focal brain ischemia but without evidence of acute infarction by neuroimaging or pathology (or in the absence of imaging).

    Measured: Minimum of 60 months and up to a maximum of 120 months

  5. Paraplegia (within 30-days)

    Paraplegia secondary to Spinal Cord Ischemia identified within 30 days following the index endovascular procedure. Paraplegia will be assessed using the SVS spinal cord ischemia grading system.

    Measured: Within 30 days of index endovascular procedure

  6. Paraparesis (within 30-days)

    Paraparesis secondary to Spinal Cord Ischemia identified within 30 days following the index endovascular procedure. Paraparesis will be assessed using the SVS spinal cord ischemia grading system.

    Measured: Within 30 days of index endovascular procedure

  7. Distal device-related thromboembolic adverse event requiring intervention or surgery (through 1-Month)

    Device-related ischemic events in tissues distal to the device implantation site resulting in bypass, open surgical or transcatheter intervention, limb amputation, or leading to death.

    Measured: Through 1 Month of index endovascular procedure

  8. Myocardial infarction (within 30-days)

    Elevated CK-MB (≥ 10x ULN) measured within 48 hours following the surgical revascularization or index endovascular procedure or need for urgent or emergent PCI/CABG within 30-days following the surgical revascularization or index endovascular procedure as confirmed at the 1-Month follow-up visit.

    Measured: Within 30 days of surgical revascularization procedure or within 30 days of index endovascular procedure

  9. Laryngeal or Phrenic Nerve injury (within 30-days)

    Irreversible laryngeal nerve injury or phrenic nerve injury requiring unplanned surgery or intervention within 30-days following the surgical revascularization or index endovascular procedure as confirmed at the 1-Month follow-up visit.

    Measured: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure

  10. Fistula formation

    Fistula detected between the aorta and any adjacent structure associated with the area treated with the endovascular stent graft system verified with direct observation or CT scan.

    Measured: Minimum of 60 months and up to a maximum of 120 months

  11. Upper extremity ischemia

    Clinically reported, device-related ischemia (Serious Adverse Event) not evident at the time of the index procedure with CTA-verified branch vessel compromise (i.e., malperfusion).

    Measured: Minimum of 60 months and up to a maximum of 120 months

  12. Lesion enlargement (treated area)

    An increase in maximum vessel (e.g., aorta or treated branch) diameter of > 5 mm in the treated region as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CT / CTA scans

    Measured: Minimum of 60 months and up to maximum of 120 months

  13. Device migration

    Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.

    Measured: Minimum of 60 months and up to a maximum of 120 months

  14. New dissection (with / without treatment)

    A new arterial tear that was not present at the time of initial presentation caused either by a stent graft, natural disease progression or iatrogenic injury during the endovascular procedure. This can include the propagation, or extension, of a previous dissection.

    Measured: Minimum of 60 months and up to maximum of 120 months

  15. Device integrity events (e.g., fracture, kinking, compression)

    Defined as any of the following:

    • Wire fractures
    • Stent kinking: Narrowing of the stent graft associated with demonstrable angulation in any of the stent components, with demonstrable flow
    • Disruption / tears in the graft component of the stent graft
    • Stent compression or invagination: Transient or permanent stent graft collapse following complete device deployment, resulting in an overall reduction in the vessel luminal diameter

    Measured: Minimum of 60 months and up to maximum of 120 months

  16. False lumen status (dissection pathology)

    Status of the false lumen both within and outside of the segment of the aorta initially treated with an endovascular stent graft:

    • Patent: Flow present throughout the entire aortic false lumen (absence of thrombus) on arterial-phase or delayed contrast-enhanced imaging.
    • Partial thrombosis: Thrombus or clot within the aortic false lumen but with a residual patent flow channel on arterial-phase or delayed contrast-enhanced imaging.
    • Complete thrombosis: Complete thrombosis of the aortic false lumen on arterial- and delayed-phase imaging.

    Measured: Minimum of 60 months and up to maximum of 120 months

  17. False lumen perfusion (dissection pathology)

    Flow into the false lumen via:

    • Type IA entry flow: Flow between the proximal endograft and aortic wall allowing systemic pressure antegrade flow into the primary entry tear and proximal false lumen.
    • Type IB entry flow: Distal entry tear adjacent to endograft due to septal fenestration or a new intimal tear at the distal aspect of the stent graft (dSINE) allowing systemic pressure direct flow into the false lumen.
    • Type II entry flow: Retrograde entry flow through arch vessel branches (innominate, carotid, subclavian) or thoracic bronchial and intercostal arteries into the false lumen.
    • Type R entry flow: Antegrade entry flow from the true lumen into the false lumen through distal branch fenestrations (uncovered intercostal arteries, visceral or renal arteries, lumbar arteries, iliac branches) or septal fenestrations (excluding SINE).

    Measured: Minimum of 60 months and up to maximum of 120 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start2 Mar 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionMar 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
GORE® TAG® Thoracic Branch Endoprosthesis (TBE)
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166133
Sponsor's protocol ID
TBE 25-03
Status last verified
Oct 2026
First submitted
2 Sep 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Study Protocol

Questions about this trial

What is this clinical trial studying?

A study testing GORE® TAG® Thoracic Branch Endoprosthesis in people with Aortic Arch Dissection and Aortic Arch Aneurysm, run by W.L.Gore & Associates at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact DeAnne Hart (800-437-8181, tbe25-03@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure (time frame: Index Endovascular Procedure Only). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07166133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in