Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

• Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.
• The absence of any additional corrective procedure related to the device, procedure, or withdrawal of the delivery system. Events will not include interventions at the access site(s), lumbar drains to address spinal cord ischemia, or additional interventions to address non-treatment areas.

Death meeting at least one of the following characteristics:

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

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

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

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

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.

No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.

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

New onset spinal cord injury rendering a subject non-ambulatory within 30 days of the index procedure

New onset spinal cord injury causing a minor motor deficit of the lower extremities within 30 days of the index procedure

New onset sustained renal failure identified within 30 days of the index procedure, combined with requiring dialysis for > 4 weeks

New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR.

Defined as any of the following:

• Wire fractures, including stents, hooks, or barbs
• 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

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

This may include surgical or interventional treatment for endoleaks, access site(s) complications, disease progression (including 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), spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery.

Complications associated with the access sites used during treatment that may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices.

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)

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

Status of the false lumen within 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.

Status of the false lumen 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.

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)

A Health Economic analysis is planned as part of the clinical registry. Initial analyses will only involve data that is collected within the registry CRFs. The objective of the Health Economic analysis is to understand the short- and long-term healthcare resource use and costs of the treatment(s) studied during the period of the clinical registry. Quality of life will also be evaluated at some sites within the Europe, Middle East and Africa (EMEA) regions and Asia-Pacific (APAC) regions, as applicable, using a standard survey.