View clinical trials related to Aortic Aneurysm.
Filter by:An abdominal aortic aneurysm occurs when the part of the aorta travelling down into the abdomen balloons out more than 50%. If caught early, treatments can be used to prevent rupture of the aneurysm. However, many of these aneurysms are asymptomatic and go undetected until they rupture, causing large amounts of blood to spill into the abdominal cavity and typically leads to death, if left untreated. The current mortality rate is between 50 and 90%. The resources required to treat patients with ruptured aortic aneurysms is quite substantial given that they need blood transfusions and can have prolonged hospital stays. Patients either undergo a more invasive operative repair, associated with greater blood products transfusions and complications, or if relatively stable, undergo a less invasive repair with tubes called stents. There is less morbidity associated with the latter, endovascular repair. To prevent blood loss in elective surgeries, drugs that promote blood clotting are often used. One drug, tranexamic acid , has been shown to reduce blood loss, reduce the number of blood transfusions required and improve patient outcomes in elective cardiac and orthopaedic surgeries, and more recently, in patients with traumatic hemorrhage. However, this drug has not been tested in this particular population. The purpose of this pilot project is to evaluate the effectiveness of tranexamic acid in reducing clinically significant bleeding in patients with ruptured aortic aneurysms in hospital sites across Saskatchewan using a single-group intervention design. The investigators will compare the data from patients treated with tranexamic acid to retrospective data from a control group that is matched on key variables. The investigators predict that tranexamic acid will result in reduced bleeding, reduced need for blood transfusions, less patients that require open surgery and improved patient outcomes. The results of this study will help determine if this treatment is effective at preventing the death of many people with ruptured abdominal aortic aneurysms.
The aim of the present study is the evaluation of cardiovascular biomarkers in patients with abdominal aortic aneurysms (AAA) or abdominal aortic occlusive disease AOD) undergoing open (OR) or endovascular aortic repair (EVAR) with regards to short- and long-term outcome. By blood collection and measurement of the serum biomarkers Copeptin, N-terminal- pro Brain Natriuretic Peptide (NT-proBNP), cardiac Troponin I (cTnI), high sensitive Troponin T (hs-cTnT) and C-reactive Protein (CRP) we expect an improvement of patients stratification by assessment of cardiac stress tolerance. Data gathered may help to simplify the decision whether an open or endovascular approach for abdominal aortic repair (OR and EVAR) should be performed. Study Hypothesis: The evaluation of the predictive value of cardiovascular biomarkers (Copeptin, NT-proBNP, hsTnT, cTnI, CRP) improve patient stratification and selection of surgical treatment.
Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities are two kinds of common surgeries in the investigators' hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive function, are not clear. In this study investigators propose to measure postoperative cognitive function and other outcome of patients who are undergoing these two kinds of surgeries, and try to identify whether there is an association between different kinds of anesthetics and postoperative outcome. Investigators will also observe whether changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative delirium or cognitive change.
A major determinant of perioperative mortality is the inability of the heart to increase its output in response to surgical stress. This is termed perioperative cardiac failure (PCF), and may only be apparent postoperatively when oxygen demand is increased. The risk of perioperative cardiac complications is the summation of the individual patient's risk and cardiac stress related to the surgical procedure1. The functional capacity of the patient determines their ability to support the postoperative demand of increased oxygen consumption, and therefore of cardiac output. Exercise capacity is one of the most powerful predictors of cardiovascular and all cause mortality2. Cardiopulmonary exercise test (CPET) is an established investigation used, among other applications, in the preoperative assessment of patient fitness for surgery3. CPET involves monitoring the electrocardiographic trace and the exhaled gas mixture (particularly CO2, whose production depends on aerobic metabolism), during incremental exercise (usually on an exercise bike), on room air. Several parameters can be measured during CPET, including maximal systemic oxygen delivery, the anaerobic threshold (the oxygen delivery value at which anaerobic metabolism begins), maximum workload, and ST segment depression/elevation (as in a standard exercise tolerance test). The cardiopulmonary "performance" during CPET has been correlated with postoperative outcome3. Pulmonary function tests will be performed in order to assess lung function. It is well known that therapy with beta-blockers in patients with ischaemic heart disease and cardiac failure reduces perioperative morbidity and mortality4-7. However, beta blockers reduce myocardial contractility and the heart rate response to adrenergic stimulation, thus blunting the physiological response to stress/surgery/exercise. Whilst this mechanism may protect the heart perioperatively, it may decrease the ability of some patients to withstand other complications. This potential decrease in "performance" has never been quantified. There is no agreement on whether preoperative CPET should be performed on or off beta-blockers and, at Aintree in particular, it is standard procedure to take patients off beta-blockers prior to their CPET. Some argue that, as beta-blockade should be maintained in the perioperative period, CPET should be performed on medications, even if these could mask the presence significant ischaemic heart disease (a significant, modifiable, risk factor for surgery by beta blockade), and even if it is not always possible to maintain beta-blockade throughout the whole postoperative period. For these reasons, other clinicians prefer to perform CPET off beta-blockers, thus, potentially, overestimating the perioperative cardiorespiratory "performance", which may be diminished once the medications are resumed. Patients on long-term beta blockade may develop some tolerance to the medications, so the effect of acute and chronic beta blockade on cardiorespiratory performance may also be different. Aim To compare cardiopulmonary performances on and off beta blockers as objectively assessed by cardiopulmonary exercise testing.
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.
This trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) for Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting period by a qualified vascular surgeon. In addition, it aims to examine the alternative sm-FBSG for patients with restricted access to centers performing clinical trials with commercially available devices and those patients with aortic emergencies.
Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.
The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.
Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years. Investigational Device The Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System. Purpose The purpose of the study is to evaluate the safety and performance of the Horizon™ AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac aneurysms. The results of this study will be used as supportive data for CE Marking submission in the European Union (EU). Objectives The primary objectives of the study are to evaluate the safety and performance of the Horizon™ AAA Stent graft System. Primary End Points Safety endpoints include proportion of patients free from device related Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance endpoints include successful delivery and deployment of the device; and absence of the following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration. Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular access techniques and devices. Treatment All patients will be treated by implantation of the Horizon™ Abdominal Aortic Aneurysm Stent graft System.
The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population. Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems to be higher in CAD population than unselected male population. This leads to hypothesis that selective screening of these patients (for AAA) could be cost-efficient and life saving option for detecting AAAs before rupture. Study will be carried out as a single-center prospective screening study. Patients will be selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient information system. Inclusion criteria will be any kind of atherosclerotic heart disease (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or treated AAA and failure to give informed consent. 800 patient records that meet the inclusion criteria will be reviewed for eligibility. Invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. Screening will be done by verified sonographers in designated screening appointments.