Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

Conditions
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Aortic Aneurysm, Thoracic, Aorta, Lesion

Intervention / Treatment
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* Device: GORE® TAG® Thoracic Branch Endoprosthesis
* Procedure: Revascularization Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2. Age ≥18 years at time of informed consent signature Subject is capable of complying with protocol requirements, including follow-up Informed Consent Form (ICF) is signed by Subject or legal representative Must have appropriate proximal aortic landing zone. Must have appropriate target branch vessel landing zone. For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone. Native aortic valve (Zone 0/1 subjects only) Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only) Exclusion Criteria: Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair Previous endovascular repair of the ascending aorta Previous endovascular repair of the DTA with a non-Gore device Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access. Infected aorta Life expectancy <2 years Myocardial infarction within 6 weeks prior to treatment Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin. Patient has a systemic infection and may be at increased risk of endovascular graft infection Pregnant female at time of informed consent signature Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome Participation in another drug or medical device study within one year of study enrollment Known history of drug abuse within one year of treatment Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access Planned coverage of celiac artery Patient has known sensitivities or allergies to the device materials Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin Patient with a history of a hypercoagulability disorder and/or hypercoagulability state Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper Mycotic aneurysm Persistent refractory shock (systolic blood pressure <90 mm Hg) Patient has body habitus or other medical condition which prevents adequate visualization of the aorta Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis Patient at high risk of neurological event, e.g. stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Zone 0/1 Aortic aneurysm<br>Zone 0/1 Aortic aneurysm | Device: GORE® TAG® Thoracic Branch Endoprosthesis<br>* Endovascular repair with the TBE Device<br>Procedure: Revascularization Procedure<br>* Revascularization procedure of the great vessel<br>|
| Other: Zone 0/1 Non-aneurysm aortic lesions<br>Includes dissection and other isolated lesion types | Device: GORE® TAG® Thoracic Branch Endoprosthesis<br>* Endovascular repair with the TBE Device<br>Procedure: Revascularization Procedure<br>* Revascularization procedure of the great vessel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort) | Composite of the following events through one month: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of the following Core Lab and adverse events: aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. | 1 month | 
| Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort) | Composite of the following events through twelve months: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of the following Core Lab and adverse events: aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. | 12 months |