View clinical trials related to Aneurysm.
Filter by:Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.
This will be a non-randomized, prospective, observational multi-center research study. Its purpose will be to assess the mortality and outcome of EVAR in patients with rAAA. As mentioned in the introduction, EVAR approach for ruptured bdominal aortic aneurysms is nowdays common clinical practice in many vascular centers , and the main treatment option in Hippokrateio General hospital. The same applies in all future participating vascular centers.
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).
Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open surgery. Intra-arterial contrast agents are an important component of successful EVAR as the tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common contrast agent, the perioperative use of IC agents is not recommended in patients with renal dysfunction or allergies to IC The aim of this study was to evaluate feasibility, efficacy and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR) in a cohort of patients with abdominal aortic aneurysm
The aim of this study is to assess blood flow velocity in middle cerebral artery measured by transcranial doppler to determine the efficacy of SCG block in decreasing incidence or severity of vasospasm after MCA aneurysm surgery.
Aortic dissection is dangerous and difficult to predict, so it is particularly important to carry out early prevention, diagnosis and rational treatment for high-risk groups. The related genes found in previous studies can not be detected in all patients with dissection; at present, the pathogenesis of non-syndromic aortic dissection is not clear, of which about 20% of patients have family aggregation and have the general representative characteristics of non-syndromic dissection. In this project, the peripheral blood samples of core family subjects were detected by sequencing technique. analyze disease-related susceptibility genes; 2 determine the effect of susceptibility genes on the incidence of dissection in mice through animal experiments; and 3 explore the effect of susceptibility genes on cell function at the cellular level.
Non-randomized, single arm, open label, academic observational study of CGuard MicroNet covered stent system use to achieve endovascular lumen reconstruction in carotid artery aneurysms with indications for treatment (enlarging and/or dissecting / symptomatic). Jagiellonian University Medical College research project.
Aortic dissection or aneurysm is unusual in young patients, and frequently associated with unusual presentations. However studies about this area is scarce. Besides, the treatment option is not clare. The prognosis of this cohort is also unclear. The goal of this study was to better understand the characters, treatment option and prognosis of young patient with aortic dissection or aneurysm.
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.
Aneurysm diameter is an important risk for rupture and related death in affected patients. This study will evaluate whether aneurysms size may even influence post procedural outcomes both in open surgical repair and in end-vascular aneurysm repair. We will retrospectively review clinical data of operated patients with abdominal aortic aneurysm. We will consider both open surgical repair and endovascular aneurysm repair procedures in order to assess the influence of aneurysm size at the time of intervention.