National Hospital for Neurology and Neurosurgery UCL Professor

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

Centre Requirements and Enrolment in ECST-2

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

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

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

Ø 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. ØA credentialing committee will approve individual centre enrolment on the basis of this documentation and any other information requested by the committee.

Ø The sequence of events for centre enrolment is:

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

Ø Once the trial credentialing committee have approved it, you have to obtain local R&D approval. Ø In the UK, this will include submitting a minor amendment to the Health Research Authority. The ECST 2 central office has a model schedule of events and statements of activities if required by the joining centre. Ø The sponsorship agreement between UCL and the site has to be signed.

Ø 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

Screening patients for ECST-2 Use the CAR Score App to screen patients before putting them into the trial Øin the i. Tunes app store the link is: https: //itunes. apple. com/gb/app/ecst-2 -car-score/id 986827121? mt=8 Øand on google play, for android users: https: //play. google. com/store/apps/details? id=com. sealedenvelope. carscore Øor access it on the web at: http: //s 489637516. websitehome. co. uk/ECST 2/CAR/index. html

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

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

Ø Discussion Ø Any questions?