Extrait

Background and study aims Abdominal aortic aneurysm is a condition where the aorta, which is the main artery that leaves the heart and travels down towards the legs, starts to bulge and expand at a section just below the diaphragm, level with the navel. If the bulge continues to expand, it can rupture and this can lead to an emergency operation and often results in death. Studies have shown that if the aneurysm increases to a certain size the risk of rupture, which is generally low, starts to increase and a planned operation can be performed to repair the bulging section of aorta. There are two ways of repairing this section and doctors are unsure which method is better. The open repair method is the tried and trusted method as it has been around for about 50 years and is known to be durable and last for the rest of most patients’ lives. However, it is quite a serious operation which generally involves a longer stay in hospital and a slightly higher chance of dying within 30 days of the operation when compared to a new method called EndoVascular Aneurysm Repair (EVAR). This new method is less of a strain on the patient’s body which results in a shorter recovery time and a better chance of surviving within the first 30 days after the procedure. The downside of this new procedure is that it is more common for there to be problems following the operation that may require further small procedures to correct them. In some cases, patients are not considered fit enough for the open repair operation as it may be too much of a strain on their body and always requires a general anaesthetic. For these patients, doctors are not sure whether repairing the aneurysm using an EVAR would be best for these patients or whether they would be better treated with regular scans of the aneurysm and given medication to try and improve their fitness. Thus, two studies have been set up to test the new endovascular method in two clinical situations: when the patient is considered fit for an open repair and when the patient is considered unfit for an open repair. Who can participate? Patients aged at least 60 with an abdominal aortic aneurysm considered fit for an open repair (EVAR Trial 1) or considered unfit for an open repair (EVAR study 2) What does the study involve? In EVAR study 1 participants considered fit for an open repair are randomly allocated to receive either an open repair or the new EVAR procedure, and these two groups are then compared to see how they get on. In EVAR study 2 participants considered unfit for an open repair are randomly allocated to receive either an EVAR with standard medical treatment or medical treatment alone, and these two groups are then compared to see how they get on. Mortality (number of deaths), quality of life, durability and cost-effectiveness are assessed. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Charing Cross Hospital (UK) When is the study starting and how long is it expected to run for? July 1999 to August 2016 Who is funding the study? 1. NIHR Health Technology Assessment Programme - HTA (UK) 2. Camelia Botnar Arterial Research Foundation Who is the main contact? Prof. Roger Greenhalgh [email protected]

Critère d'inclusion

• Cardiovascular diseases: Peripheral arterial disease

Liens

• ictrp
• isrctn