View clinical trials related to Aortic Aneurysm, Thoracic.
Filter by:The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.
The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
The 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.
Advanced Endovascular repair of aneurysms and dissections involving thoraco-abdominal (type I-IV) and complex abdominal (juxta and para-renal) aorta is a ground-gaining procedure allowing favorable results in high surgical risk patients. The availability of iliac vessels navigation and the major role of lower leg perfusion in order to decrease the risk of spinal cord ischemia during these complex procedures, led to the development of devices with lower sheaths sizes and to the improvement of the technique with preloaded devices for visceral vessels in order to navigate in hostile anatomies or when an iliac access is not available. The aim of the study is to evaluate in a prospective single center observational setting, the outcomes, safety and efficacy of the modified preloaded system for renal arteries in fenestrated endografting in the routine treatment of paravisceral and thoraco-abdominal aortic pathologies.
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
The Diagnosis of a thoracic Aortic Aneruysms usually made when imaging an abdominal aortic aneurysm which has reached threshold or as an incidental finding during a chest scan by computed tomography (CT) or magnetic resonance imaging (MRI). However, these imaging modalities are expensive, involve radiation exposure and can cause anaphylaxis and other allergic reaction from the contract agents used. In addition CT scans are contraindicated for those who have: allergic reactions to the contrast, radioactive iodine treatment for thyroid disease, metformin use, and chronic or acutely worsening renal disease. Ultrasound is a non-invasive imaging modality that is cheaper than the methods currently used for TAA detection and surveillance. Echocardiography is limited in assessing the TAA as it is not sensitive to image beyond the proximal ascending aorta which is why it is currently not used for screening or surveillance. A pilot study found that ultrasound has the potential to be used as a diagnostic modality for thoracic aortic aneurysms and may have a role in surveillance in patients for whom CT scanning is contraindicated. They found that the sensitivity and specificity of detecting TAA was 100% and 70% for a threshold of 35 mm, and 84% and 90% for a threshold of 40 mm. However, further validation of this methodology is required for it to be considered as a method of diagnosis and surveillance for this patient group. This study was only carried out by one experienced sonographer so it important to repeat this study to see if other sonographers are able to obtain the necessary views. The main purpose of this study is to validate the protocol used by pilot study to assess whether thoracic aortic aneurysms can be detected and measured accurately using ultrasound. There are two main objectives of this study: 1. Can ultrasound be used to detect thoracic aortic aneurysms? 2. Can ultrasound be used to accurately measure thoracic aortic aneurysms? If the results of this study show that ultrasound has high sensitivity and specificity for detecting thoracic aortic aneurysms, it could lead to a thoracic aorta screening programme.
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
Minimally invasive aortic valve (AV) surgery has become widely accepted alternative to standard sternotomy. Despite possible reduction in morbidity, this approach is not routinely performed for aortic surgery. Evidence exists, however, on safety of this approach together with promising results regarding its long-term durability. The MIRAGE Registry is aimed to collect and analyse the data from multiple aortic excellence centres and to analyse them in numerous clinical scenarios.
A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.