Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2

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, requiring Zone 2 proximal implantation of the device.

Detailed Description
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For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 2 Subjects enrolled for analysis were from the United States only.

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, Zone 2

Conditions
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Aortic Aneurysm, Thoracic, Aorta; Lesion

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


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. 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

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Zone 2 Aneurysm<br>Includes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2. | Device: GORE® TAG® Thoracic Branch Endoprosthesis<br>* Endovascular repair with the TBE Device<br>|
| Other: Zone 2 Non-aneurysm<br>Includes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2. | Device: GORE® TAG® Thoracic Branch Endoprosthesis<br>* Endovascular repair with the TBE Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Primary Endpoint Success for Zone 2 | Primary Endpoint was composite of the following events: device technical success and absence of 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/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis. | 12 Months |