Extrait

Background and study aims One in every 1000-2000 people in the UK will be diagnosed with advanced cases of Severe Limb Ischemia (SLI) yearly. As a result of a combination of smoking, diabetes, high blood pressure, high cholesterol levels, kidney failure and the ageing process, some people develop ‘hardening’ of the arteries in their legs. In SLI, even minor injuries to the foot can fail to heal, resulting in the development of ulceration, even gangrene. Unless the blood supply to the leg and foot is improved, many people affected by SLI will lose their limb and/or die within 12 months. As well as causing great suffering, SLI places a large financial burden upon health and social care services. The two treatments currently available for SLI are vein bypass (VB) and best endovascular treatment (BET). In VB a vein is used to bypass the blockage. BET involves opening up the diseased arteries with balloons and sometimes the use of little metal tubes called stents. Both treatments have pros and cons and there is debate and uncertainty as to which is preferable, when, in which arteries, and in which patients. Who can participate? This study aims to recruit 600 adult patients with SLI from the participating hospitals. What does the study involve? Patients will be randomly allocated to receive either vein bypass surgery or the best endovascular treatment. Patients will be followed up clinically for 3 years and asked to complete questionnaires at 10 time points over this time. The 10 time points have been selected to occur at the same time as the patient would normally have a clinical appointment - there are no additional appointments. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? The study is run from about 40 hospitals within the British Isles. When is the study starting and how long is it expected to run for? The study runs from May 2014 until October 2019. Recruitment starts in May 2014 and continues for 3 years. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? Clinical Lead: Professor Andrew Bradbury, [email protected] Administrative contact: Mr Hugh Jarrett, [email protected]

Critère d'inclusion

• Severe ischaemia of the lower limb due to infrageniculate arterial disease

Liens

• ictrp
• isrctn