Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
NCT Number: NCT06507865
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aneurysm|Dissection, Aortic|TAA Thoracoabdominal Aortic Aneurysm|Thoracic Aortic Aneurysm|Transection Aorta
Interventions: DEVICE: GORE® TAG® Thoracic Branch Endoprosthesis
Sponsor: W.L.Gore & Associates
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01
Completion Date: 2031-04
Locations: Medizinische Universität Wien, Wien, A-1090, Austria|Rigshospitalet University Hospital, Copenhagen, 2100, Denmark|Universitätsklinikum Carl Gustav Carus Dresden, Dresden, 01307, Germany|University of Heidelberg, Heidelberg, 69120, Germany|Universitätsklinikum Schleswig-Holstein, Kiel, 24105, Germany|Universitätsklinikum Münster, Muenster, 48149, Germany|Evangelismos General Hospital, Athens, 106 76, Greece|Laiko General hospital of Athens, Athens, 11527, Greece|Policlinico di Sant'Orsola, Bologna, 40138, Italy|ASST Spedali Civili di Brescia, Brescia, 25123, Italy|IRCCS Ospedale Policlinico San Martino, Genova, 16132, Italy|AOU Padova, Padova, 35128, Italy|Amsterdam UMC, Amsterdam, 1105 AZ, Netherlands|Radboud UMC, Nijmegen, 6525 GA, Netherlands|Complejo Hospitalario Universitario de Vigo, Vigo, 36312, Spain|Hospital Universitario Miguel Servet, Zaragoza, 50009, Spain|Skane University Hospital, Malmö, 205 02, Sweden|St Thomas' Hospital, London, SE1 7EH, United Kingdom|St Mary's Hospital, London, W2 1NY, United Kingdom

Summary:
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.

Primary Outcome Measures: 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., Time of Surgery|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., Day 30 through Year 2|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., Time of Surgery through Year 2|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., Time of Surgery through Year 2|Endoleaks (Type I-V), Perfusion of a treated lesion identified through imaging analysis., Time of Surgery through Year 2|Device Migration, 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., Time of Surgery through Year 2|Loss of Aortic / Branch Patency, No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation., Time of Surgery through Year 2|Stroke, 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 either persists for \> 24 hours or until death or symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction., Time of Surgery through Year 2|Paraplegia, New onset spinal cord injury rendering a subject non-ambulatory., Time of surgery through Day 30|Paraparesis, New onset spinal cord injury causing a minor motor deficit of the lower extremities., Time of surgery through Day 30|New Onset Renal Failure, New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for \> 4 weeks., Time of surgery through Day 30|Renal Function Deterioration, New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR., Time of surgery through Year 2|Device Integrity Events, wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis., Time of Surgery through Year 2|Reintervention, 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., Time of Surgery through Year 2
Secondary Outcome Measures: 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., Time of Surgery through Year 2|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), Time of Surgery through Year 2|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., Time of Surgery through Year 2|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), Time of Surgery through Year 2|False Lumen Status - Treated Segment, Status of the false lumen within the segment of the aorta initially treated with an endovascular stent graft. It is divided in patent, partial thrombosis and complete thrombosis., Time of Surgery through Year 2|False Lumen Status - Untreated Segment, Status of the false lumen outside of the segment of the aorta initially treated with an endovascular stent graft. It is divided in patent, partial thrombosis and complete thrombosis., Time of Surgery through Year 2|False Lumen Perfusion, Flow into the false lumen via Type IA entry flow, Type IB entry flow, Type II entry flow and Type R entry flow., Time of Surgery through Year 2