View clinical trials related to Aortic Aneurysm, Abdominal.
Filter by:The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR protocol include: appropriate patient selection, bilateral percutaneous access, no general anesthesia, no ICU admission post procedure, and next day discharge.
The primary aim of the study is to determine if the evolutivity of global and segmentary captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally and segmentary in angioscan.
Specific cardiovascular diseases, such as stroke and heart attack, have been shown to vary by ethnic group. However, less is known about differences between ethnic groups and a wider range of cardiovascular diseases. This study will examine differences between ethnic groups (White, Black, South Asian and Mixed/Other) and first lifetime presentation of twelve different cardiovascular diseases. This information may help to predict the onset of cardiovascular diseases and inform disease prevention strategies. The hypothesis is that different ethnic groups have differing associations with the range of cardiovascular diseases studied.
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.
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.
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.
Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause of death in Europe and North America. A key limitation of contemporary treatment strategies of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an effective treatment for large AAA, it is associated with significant mortality and morbidity as well as substantial cost. The rationale for this randomized controlled study is to investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic aneurysms.
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.
The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm. Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.