Extrait

Background and study aims Peripheral Arterial Disease (PAD) is a disease that is caused by accumulation of fatty deposits in the blood vessels that supply the leg muscles. In the western world, it affects 20% of adults older than 55 years. This is about 27 million people in Europe and the United States. This disease can be silent in nature with patients presenting to their doctor with intermittent pain associated with exercise and relieved by rest. The treatment, called Peripheral Transluminal Angioplasty (PTA), involves puncturing an artery in the leg and inserting a balloon that will be inflated at the point of blockage to increase the blood supply to the leg. At present, there is very little evidence regarding the most effective length of time for balloon inflation, and the long­ term effect depends on the operator and the centre. With this study we aim to find out if using a specific balloon inflation time can improve the treatment outcomes and the patient's quality of life. Who can participate? This study aims to recruit 50 patients suffering from symptomatic arteriosclerotic disease and who have been selected to undergo Peripheral Transluminal Angioplasty (PTA). What does the study involve? PTA will involve puncture of an artery in the leg and insertion of a balloon that will be inflated at the point of blockage to increase the blood supply to your leg. Patients will be allocated randomly into one of two groups: a 60 second group or a 180 second group. If you are in the 60 second group and the initial inflation fails, then a further 180 second inflation will be performed. If further treatment is required after the balloon inflation has occurred then this will be performed. This will lead to four groups of patients: 1. Successful angioplasty with 60 seconds 2. Successful angioplasty with 180 seconds 3. Successful angioplasty with 60 + 180 seconds 4. Unsuccessful angioplasty requiring further immediate treatment Patients will then take part in a questionnaire that will ask about exercise tolerance and general well-being. Follow up will be at 8 weeks, where the patient will be checked after post procedure and their blood pressure readings are taken. The 1-year follow-up is an appointment specifically for those patients in the study and will involve repeat questionnaires to see the effect on quality of life and exercise capacity. What are the possible benefits and risks of participating? There is no clinical benefit to participating in the study. However, taking part in a clinical study is a rewarding process. There are no additional risks from undertaking this study. The general risks of the procedure are bleeding and infection Where is the study run? The study will be run at the Hull Royal Infirmary, UK. When is the study starting and how long is it expected to run for? The trial is expected to start recruitment from late March to early April 2014 and will aim to finish mid-2015, with full follow-up of patients performed by mid-2016. Who is funding the study? The British Society of Interventional Radiology (BSIR), UK. Who is the main contact? Dr Aubrey Smith [email protected]

Critère d'inclusion

• Claudication

Liens

• ictrp
• isrctn