View clinical trials related to Aortic Aneurysm.
Filter by:Comparative study on efficacy of haemostatic therapy guided either by standard laboratory coagulation parameters or point-of-care testing in patients undergoing vascular surgical procedures. We investigate the amount of perioperative bleeding and the number of blood product used. Inclusion criteria Patients scheduled for elective and acute open aorta surgery or undergoing acute aorta surgery with minimally invasive techniques and were provided treatment in the operating theatre and/or ICU attached to perioperative care, they must be at least 18 years of age and written informed consent was obtained from the patient or his/her legal representative. Randomisation technique Patients will be randomly assigned to each of two treatment groups using sealed envelopes. In group 1 (G1) haemostasis strategy guided by conventional coagulation tests, while in group 2 (G2) transfusion algorithms guided by point-of-care (POC) tests will be carried out. Sampling techniques and measurements For assessment of monitored parameters shall be used arterial or venous blood depending on the catheter placed preoperatively. In case of the above mentioned vascular surgical procedures, all patients will receive arterial cannula routinely, and, depending on the extension of procedure, as appropriate, a central venous catheter will be inserted as well. Sampling in the patient groups shall be performed as follows: - pre- and postoperative evaluation of standard laboratory parameters in all patients - evaluation of standard laboratory parameters and arterial Astrup test during and after surgery in group 1, if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes - in case of elective surgery: thromboelastometry and arterial Astrup test during and after surgery in group 2 if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes - in case of acute surgery: thromboelastometry and arterial Astrup test before, during and after surgery in group 2 - in case of positive anamnesis, preoperative platelet aggregation test in both groups Besides the above samplings, routine lab tests (blood gas, blood count, sodium (Na), potassium (K), parameters of renal and liver function, clotting and inflammation, lactic acid, blood sugar) will be performed every day as usual during intensive therapy.
Serum uric acid level is a commonly measured biomarker. The association between serum uric acid level and the risk of developing cardiovascular diseases has been observed in some studies, while others showed controversial results. Estimation of this association may help to predict cardiovascular outcomes and may guide new treatment strategies. The hypothesis is that increased serum uric acid level is associated with a range of cardiovascular diseases.
This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.
This study tests the use of a decision aid for Veterans who are facing a decision about surgery for their Abdominal Aortic Aneurysm (AAA). The local site investigators (LSI) will enroll Veterans with AAA who are candidates for endovascular or open surgical repair. There are 22-24 VA Medical Centers participating in the trial. 12 sites will be randomly assigned to the intervention group, and 12 sites will be randomly assigned to the control group. Twelve Veterans will be enrolled at each site. At sites assigned to the intervention arm, Veterans will receive a decision aid with information about the two types of surgery for AAA repair, open and endovascular, and complete a survey about their preferences. Veterans at control sites will complete the same survey, but will not receive the decision aid. After their surgery, Veterans will take another survey asking about their satisfaction. The LSI will compare the results of the survey between Veterans' in the intervention and control groups to determine the effect of the decision aid on agreement between preference and repair type.
The 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.
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)
The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.