Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic AneurysmsDissecting9 moreThe purpose of this study is to assess the role endovascular therapy to treat aortic disease involving the ascending aorta, the aortic arch, and the visceral segment of the aorta (or thoracoabdominal aorta)
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions...
Aortic AneurysmThoracic2 moreThe 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.
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic...
Aortic AneurysmThoracic1 moreInvestigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections...
Aortic AneurysmThoracic1 moreThe purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps. The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B dissections.
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending...
Aortic AneurysmThoracic1 moreThe 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.
Endovascular Repair of Thoracoabdominal Aortic Aneurysms
Thoracoabdominal Aortic AneurysmThe primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Visceral Manifold Study for the Repair of TAAA
Thoracoabdominal Aortic AneurysmsThe outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study. The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch...
Thoracoabdominal Aortic AneurysmThe INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with thoracoabdominal aortic aneurysms.
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Thoracic Aortic AneurysmThoracic Aortic Dissection6 moreThe ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. The secondary objective is to evaluate the safety and clinical performance of the studied devices.
Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
Rare DiseasesAortic Aneurysm1 moreThe goal of this observational cross-sectional study is to learn about vagal features in patients with syndromic and non-syndromic TAA. The main question it aims to answer is to highlight a functional condition that could help stratify patients with TAA on the risk of aortic complications. Participant will take part by standing in supine position for 10 minutes and during active standing for 10 minutes. In this period of time, it will be possible to acquire the signals continuously and non invasively through recorded non-invasive blood pressure and piezoelectric sensor breathing belt.