Frequently Asked Questions

Why might I want to take part in this trial?

You may be at a somewhat increased risk of having a stroke because you have a narrowing in one or both of your carotid arteries (the arteries in the neck that supply blood to the brain) and you and your doctor are uncertain which of these two methods of treating carotid artery narrowing would be better for you. Although you don’t have any symptoms at present, removing this narrowing can reduce your risk of having a stroke over the next few years. Treating the narrowing also has some risks which your doctor will explain to you.

Do I have to take part?

No. It is up to you to decide whether or not to take part. If you do decide to take part, you will be given an information sheet to read and keep, and will be asked to sign a consent form. You are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.

What will happen to me if I take part?

If you do take part in this study, you will be allocated one of the treatments described below. You will have an equal chance of being put into one of the two study groups listed below:

• Group A: This group will be treated by carotid endarterectomy (CEA)

or

• Group B: This group will be treated by carotid artery stenting (CAS)

Will there be any other tests or procedures?

If you decide to take part, you will be asked to sign a consent form saying that you agree to do so, and your family doctor will be sent a letter saying that you have done so.

On the consent form you will be asked to give the contact details of your family doctor and of 1 or 2 friends or relatives, so we can ask them how you are if we lose contact with you. Please be ready to provide these details if you think you might join the study: see below.

The study does not require you to have further tests than your routine tests decided by your doctor.

What does carotid endarterectomy involve?

CEA involves surgery, under general or sometimes local anaesthetic, to unblock the inside of the narrowed part of the artery in the neck. We know already that this operation involves some immediate risk, but that it does provide long-term protection against the narrowing causing a stroke.

What does carotid artery “stenting” involve?

This involves inserting a tube inside the narrowed part of the artery to hold it open. CAS avoids operating on the neck, as the tube is inserted via an artery some distance away (usually in the leg), often with only a local anaesthetic. CAS might be safer than and as effective as CEA at preventing stroke, but currently there is not enough information to know this reliably. 

What happens after I have had the procedure?

Your doctor will want to see you about 1 month after the procedure has been done to assess your general health. In this visit they will ask you questions about your health since the procedure. Your blood pressure will be taken and you may have an ultrasound scan to your carotid arteries to see how effective the procedure was. Your doctor will fill in a one month follow up form to send to the trial office.

After the one month follow up your doctor or our office will send you a form once a year for 5 years to find out how have you been feeling since the procedure. The form will only take about 5 minutes to be completed, and a reply paid enveloped will be attached for your convenience.

When will the study results be available?

It will take some years to enroll enough patients to make the study large enough to be reliable, and these patients will then have to be followed up for some years after their treatment to compare the long-term effects of CEA and CAS. While the study is in progress its early findings (and any other new relevant information) will be continually monitored to ensure that the study remains appropriately safe and viable. Long after you join, the final results will be freely available on the study website and published in a scientific medical journal, but neither you nor other patients will be identified when this happens.

What will happen if I don’t want to carry on with the study?

Taking part in this study is voluntary. You may choose not to take part in the study, or choose to leave the study at any time. The quality of your medical care will not change should you choose not to take part in the study or decide to leave the study early.

Will my taking part in the study be kept confidential?

We want to collect only the information that is required to help compare CEA with CAS (although we may find we can also use this information for other medical research to help future patients). The information will be treated in strict confidence, held by the study organisers on secure databases on UK University computers, and retained for a minimum of 15 years. Your medical records may be inspected confidentially by trial regulators and other properly authorised persons to check that we are doing the study properly. Otherwise, any information released outside the trial’s office will not identify you.