View clinical trials related to AAA.
Filter by:Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).
An abdominal aortic aneurysm (AAA) is a dilation of the aorta, defined as an aortic diameter of ≥3cm. It is a significant cause of death internationally and in England each year causes c.4,000 deaths with 8,000 patients undergoing preventative surgery. AAA are often asymptomatic and there is a latent period between development and rupture. This represents an opportunity to screen by ultrasound which has been shown in trials to reduce AAA related mortality by half. In England this evidence is based on a randomised trial data from the late nineties, however, since these data were published the number of men identified with AAA has fallen to a current prevalence of just over 1%. Furthermore, similarly designed randomised trials in Western Australia demonstrated no meaningful differences in AAA or cardiovascular deaths. The first aim of our research is to follow men who have been screened for AAA in England in order to establish the medium (5 years) and long term (10+ years) impact of AAA screening on the risk of a AAA, cardiovascular and all-cause morbidity/mortality in a non-trial setting. Men with sub-aneurysms will be examined (Aorta=2.5-2.9cm) as several studies suggest this group is at risk of late rupture. The role of patient pathways to improve uptake of the screening programme will be examined. Current data suggests that the most 'deprived' men in England are the least likely to turn up for screening but the most likely to have an abdominal aneurysm. Outcomes in this group will be analysed including the benefit of a new patient pathway to improve uptake nationally. Lastly, several large studies have demonstrated that a larger aortic diameter may be associated with cardiovascular risk. The addition of aortic diameter to current risk prediction models could improve the accuracy of these models and will be examined.
This study will assess the safety and efficacy of systemic (IV) administration of escalating doses of allogeneic MSCs in modulating immune cell phenotypes and suppressing aortic inflammation in patients with small AAA. Subjects will be randomized in a 1:1:1 fashion to receive mesenchymal stromal cells (1 million or 3 million MSC/kg) intra-venously or placebo (Plasmalyte A).