NCT07166133 · W.L.Gore & Associates
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
What this study is about
A forward-looking 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.
View original scientific description
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.
Interventions
DEVICE
GORE® TAG® Thoracic Branch Endoprosthesis
Lesions in aortic arch in Zone 0 or Zone 1
Primary outcome measures
Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure
Time frame: Index Endovascular Procedure Only
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.
Device Technical Success (index procedure only)
Time frame: Index Endovascular 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.
Lesion-related mortality
Time frame: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure
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.
Disabling Stroke
Time frame: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure
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.
Permanent Paraplegia (within 30-days)
Time frame: Within 30 days of index endovascular procedure
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
Permanent Paraparesis (within 30-days)
Time frame: Within 30 days of index endovascular procedure
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.
New onset renal failure (within 30-days) requiring on-going dialysis
Time frame: Within 30 days of index endovascular procedure
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.
Lesion rupture (treated area)
Time frame: Minimum of 60 months and up to a maximum 120 months
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
Loss of aortic or branch patency
Time frame: Minimum of 60 months and up to a maximum of 120 months
No flow or contrast detected through the implanted aortic component or endovascular branch component confirmed with imaging and/or direct observation.
Endoleaks
Time frame: Minimum of 60 months and up to a maximum of 120 months
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.
Reintervention
Time frame: Minimum of 60 months and up to a maximum of 120 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Scottsdale, Arizona
- Los Angeles, California
- Hartford, Connecticut
- Washington D.C., District of Columbia
- Gainesville, Florida
- Lakeland, Florida
- Tampa, Florida
- Chapel Hill, North Carolina
- Durham, North Carolina
- Philadelphia, Pennsylvania
- Houston, Texas
- Plano, Texas
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations