Extrait

Background and study aims Peripheral arterial disease (PAD) is a common condition in which the blood flow to the legs is restricted. This happens because of the buildup of a fatty substance (plaque) on the walls of arteries. Over time this can cause the main arteries in the legs to become narrowed (stenosed) or blocked (occluded). As the arteries become narrower, patients begin the feel pain even when at rest and are at severe risk of developing ulcers or gangrene (acute lower limb ischaemia), which in severe cases can lead to amputation. Many patients are treated with blood thinning medication or surgery to restore blood flow to the leg (revascularisation), however these treatments are not always successful. Today, the most popular and frequently used treatments are surgery and/or thrombolysis. Thrombolysis is a treatment which involves breaking down blood clots which may be blocking the arteries using a type of medication called thrombolytics. They are administered through catheter (tube) inserted into the major artery in the groin. Both therapies are associated with high death rate and serious complications. Catheter therapy itself is less invasive than surgical treatment and therefore, different catheters have been developed that can break up the clot mechanically (mechanical debulking). However, mechanical removal has not replaced the traditional treatment so far, mainly due to limited experience with the new techniques as well as low efficacy of those approaches alone which often requires a combination with thrombolysis. The aim of this study is to find out whether mechanical debulking can be successfully and safely used without having to use thrombolysis and/or open surgery. Who can participate? Adults with symptomatic acute lower limb ischaemia. What does the study involve? All participants undergo treatment using the mechanical debulking method. This involves a catheter (thin, flexible tube) being inserted into the main artery in the affected leg via the groin and used to mechanically break down the blood clot. Participants are monitored closely for any complications until they are discharged from hospital. In addition, they undergo blood vessel scans to see if the arteries have become successfully unblocked at discharge and after 30 days and 12 months. In addition, the number of patients who require further treatment, such as amputation or thrombolysis, are recorded for one year. What are the possible benefits and risks of participating? Participants may benefit from a better chance of survival and lower complication rate. In addition, patients who are unable to have traditional treatment for medical reasons benefit from being able to receive treatment. There is a small risk of a blockage to blood flow or blood vessel perforation (piercing). Where is the study run from? University Hospital and 3rd Medical Faculty of Charles University (Czech Republic) When is the study starting and how long is it expected to run for? January 2009 to December 2016 Who is funding the study? Investigator initiated and funded (Czech Republic) Who is the main contact? Professor Miroslav Bulvas [email protected]

Critère d'inclusion

• Acute and subacute ischeamia of lower limbs

Liens

• isrctn