Woman and Man
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Extract
Background and study aims About 85% of strokes are ischemic strokes, in which the blood flow to the brain is blocked by a blood clot (ischaemia). As we age, deposits of a fatty substance called plaque can build-up in the main arteries in the neck (carotid arteries). Over time, this plaque can greatly reduce the diameter of the arteries (stenosis), even blocking them all together (occlusion). If the artery is particularly stenosed (with a reduction in diameter of more than 50%) surgical treatment may be recommended to restore blood flow, reducing the risk of stroke. Traditionally, this is done using a procedure called a carotid endarterectomy, in which the blockage itself is removed through a surgical incision (cut). Carotid angioplasty and stenting is an alternative, less invasive procedure which is becoming more popular. This is considered to be a good alternative to open surgery as it is less risky and so can be used for people who are too unwell for an endarterectomy. It is done by placing a thin tube (catheter) into a large artery (usually in the leg) and guiding it to the stenosed carotid artery. A small balloon is then inflated to “flatten” the blockage against the artery wall and a stent (small mesh tube) is placed inside in order to keep the artery open. The aim of this study is to compare the risks and benefits of these two procedures in patients with carotid stenosis. Who can participate? Adults over 40 years of age with a narrowing of their carotid arteries of at least 50%. What does the study involve? Participants are randomly allocated to one of two groups. Participants in the first group receive a carotid endarterectomy procedure. This involves a small cut being made in the narrowed section of the affected artery (accessed through a cut in the neck), so that the plaque can be removed by the surgeon before it is stitched closed again. Participants in the second group receive carotid artery stenting. This involves the surgeon inserting a catheter (thin tube) into the main artery of the leg (femoral artery) and guiding it up to the narrowed carotid artery with help from a special dye visible on a type of x-ray (angiogram). A guide wire inside the catheter is then used to manoeuvre the stent and balloon into the carotid artery. The balloon is placed inside the stent and inflated in order to open the stent and push it into place against the artery wall. The balloon is then deflated and removed, leaving the stent in place. Participants in both groups are then followed up in order to record the number of people who suffer from a stroke or die. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? University College London (UK) When is the study starting and how long is it expected to run for? May 2000 to December 2010 Who is funding the study? Medical Research Council (UK) Who is the main contact? Professor Martin Brown [email protected]
Inclusion criteria
- Carotid stenosis/stroke