View clinical trials related to Aortic Aneurysm, Thoracic.
Filter by:This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.
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.
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic aneurysms.
The study aims to investigate the applicability of intravascular ultrasound (IVUS) in the endovascular therapy of juxta-, supra- and thoracoabdominal aortic aneurysms. The focus of the study is on the intraoperative and postoperative evaluation of the geometric data of bridging stentgrafts in terms of patency, occurrence of stenosis and/or kinking.
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.
The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.
Observational prospective pilot study to analyze the trajectory of neuroinflammatory protein expression in cerebrospinal fluid (CSF) in relation to systemic compartment in patients undergoing thoracic aortic surgery. The aim of this study is to identify and unravel the biochemical (neuroinflammatory) pathways involved in postoperative delirium. Patient undergoing thoracic aortic surgery will have an external lumbar drain (ELD) in situ on the day before surgery. This ELD remains in place during and three days after surgery to reduce the risk on periprocedural spinal cord ischemia. Paired measurements of CSF and blood will be analyzed.
Study Design This is a prospective, multicenter, non-randomized clinical study in patients presenting thoracic aortic pathologies. Following a baseline assessment, the implantation procedure will be performed according to the Instructions for Use and local routine practice. A follow-up visit will be performed 30 days, 6, 12,24 and 36 months after the implantation procedure. The investigator will perform assessments of the implantation procedure and device system and document adverse events (AE) and device deficiencies. Resources utilization and unit costs will be collected at index procedure and during follow-up. HRQoL is going to be investigated in this prospective study using the generic questionnaire EQ5D 5 levels, comparing pre- and postoperative scores. Study Objective The objective of the study is to evaluate the safety, performance and resource utilization associated with the use of GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL systems in humans having thoracic aortic pathologies. Safety will be evaluated considering mortality and morbidity variables (mainly focused on device related complications). Efficacy will be evaluated according to the variables related to the technical and clinical successes. In addition, resource utilization and associated costs will be collected prospectively with the objective to analyze differences in resource utilization between outcome groups, landing zone groups, disease severity groups, adverse event groups and case-mix groups. We will calculate the average marginal costs increase for complications when they occurred during TEVAR or surgical revascularization (e.g., paralysis, stroke, nerve injury, lymph damages, myocardial infarction, major bleeding event, respiratory complication). Resource utilization analysis is not going to be limited to the index procedure but will continue during follow-up. Subject Population: Elective and Urgent Thoracic aorta pathologies such as aneurysms, pseudoaneurysms, dissections, blunt thoracic aorta injury, penetrating ulcers and intramural hematoma. Planned number of patients: A total of 200 patients. Approx. 20 study centers in 2 European countries (15 in Italy and 5 in Spain) . A subgroup of 8centers will be selected for the micro-costing analysis (7 in Italy and one in Barcelona) Expected Time to Complete Enrollment: end of 2021 (18 months).
The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal loop graft" "custom made "CE equivalent" branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta