The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.
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Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with TBE at participating sites. Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry. The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a TBE product has been made prior to considering the patient for possible registry participation. The TBE registry population will be defined as a successful recipient of TBE at the end of the index procedure.
Cohort
Prospective
GORE® TAG® Thoracic Branch Endoprosthesis
DevicePatients presenting with thoracic vascular disease that may benefit from the placement of TBE device. The target registry population is patients who are treated with TBE at participating sites. TBE treatment is qualified as receiving the TBE aortic component, at a minimum.
Deployment Technical Success
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.
Lesion-related Mortality
Death related to the index endovascular procedure or following conversion to open repair and death related to 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.
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.
Lesion Enlargement (treated area)
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.
Access-related Complications
Complications associated with the access sites used during treatment and any subsequent unplanned access-related reinterventions. This may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices.
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)
Life Threatening Bleed
An event leading to either diagnosed hypovolemic shock, required four or more packed red blood cell units or directly led to subject death.
Upper Extremity Ischemia
Clinically-reported, device-related ischemia not evident at the time of the index procedure with CTA-verified branch vessel compromise (i.e., malperfusion)
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