1. National Hospital for Neurology and Neurosurgery,
UCL
Professor Martin Brown
Chief Investigator
Mrs Ekaterina Biggs
Trial Manager

2. Centre Requirements and Enrolment in ECST-2

3. Each centre must have:
A neurologist or physician with an interest in stroke to see patients prior to randomisation and to supervise follow up.
Surgeon to perform revascularisation.
Be able to perform MRI on trial patients.
A process for ensuring that the management of individual patients is routinely discussed by the neurologists or stroke physicians, surgeons, and radiologists or interventionists.

4. Carotid endarterectomy (CEA) must be carried out by designated surgeons with expertise in the operation

5. In centres planning to offer carotid stenting, this must be carried out by a designated and appropriately qualified interventionist.

6. Centres will be required to submit documentation demonstrating the training and experience of their investigators, and an audit of the outcomes of carotid revascularisation at their centre.
A credentialing committee will approve individual centre enrolment on the basis of this documentation and any other information requested by the committee.

7. The sequence of events for centre enrolment is:

8. Complete the centre enrolment form and return it to me either as a scanned copy by or by post .
Ensure you have supplied the surgeon/ interventionist audit figures and the declaration page has been signed.
Ensure you return CVs for the persons named on the form.

9. Once the trial credentialing committee have approved it, you have to obtain local R&D approval.
In the UK, this will include submitting a minor amendment to the Health Research Authority. The ECST2 central office has a model schedule of events and statements of activities if required by the joining centre.
The sponsorship agreement between UCL and the site has to be signed.

10. Once all the above have been completed a Site Initiation Visit will take place (this may be by telephone conference) after which the site may begin to randomise patients

11. Screening patients for ECST-2
Use the CAR Score App to screen patients before putting them into the trial
in the iTunes app store the link is:
and on google play, for android users:
or access it on the web at:

12. NB Since the last protocol amendment has been approved the CAR score threshold for randomisation has increased to 20% - check you are using the latest version of the app:
1.1.0 on Google Play
1.1.1 on App Store

13. What we need to do to meet our targets
Enrol more centres
Recruit more patients at the enrolled centres
What are the barriers to this?
Meeting centre requirements
Finding, screening and randomising patients
Willingness of patients to be randomised

14. Discussion
Any questions?