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Does vertebral artery stenting prevent recurrent stroke in symptomatic vertebral artery stenosis? September 2015 TitleNameEmailTrial Office Number Trial.

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Presentation on theme: "Does vertebral artery stenting prevent recurrent stroke in symptomatic vertebral artery stenosis? September 2015 TitleNameEmailTrial Office Number Trial."— Presentation transcript:

1 Does vertebral artery stenting prevent recurrent stroke in symptomatic vertebral artery stenosis? September 2015 TitleNameEmailTrial Office Number Trial ManagerDr Lindsay Davieslad47@medschl.cam.ac.ukT: 01223 348401 Chief Investigator & Lead NeurologistProfessor Hugh Markushsm32@medschl.cam.ac.uk- Lead Neuroradiologist, St. George’sDr Andrew CliftonAndrew.clifton@stgeorges.nhs.uk- Lead Neuroradiologist, OxfordDr Wilhelm Kükerwilhelm.kuker@ndcn.ox.ac.uk- www.vist.org.uk This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 11/129/16) and will be published in full in Health Technology Assessment. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health. New Trial Manager – Dr Lindsay Davies VIST has a new Trial Manager! There has been a little gap without a full- time Trial Manager, and we are very grateful to Maria Spillane for her help in covering the role. I would like to introduce myself to you, having taken over the role from Maria part- time since August 3, and now full-time from September.. A little overview about me – starting life as a Zoologist, I have a long and varied experience in clinical research, including data management, managing a small Dermatology CTU (NHS Hospital) running academic and commercial trials, working for a large Pharma managing a Global Submission Team in Switzerland and Belgium, and latterly for a UK-based CRO, managing a team of Study Start Up PM’s on a portfolio of 14 trials for a single (Japanese) Sponsor. Alongside that I have raised four (large) sons, and moved around the globe with my family, living and working in various parts of the world, including Hong Kong, Australia, Russia and Europe. FIRST RELEASE OF VIST RESULTS – upcoming early 2016. We are planning to release first VIST results early in 2016, once all patients have reached 1 year follow up, although long term follow up will be continuing. Therefore it is very important that we have all Site follow up data complete by February 2016. It will be exciting to see what the results show, and so we really appreciate your help with this. I am excited to be joining the VIST team, getting to know you all, and supporting this final phase of the trial. I would like to thank Maria for her great handover and guidance on the status of the trial to this point.

2 Does vertebral artery stenting prevent recurrent stroke in symptomatic vertebral artery stenosis? September 2015– Page 2 Final Recruitment Summary # Patients per Centre 77 St. George’s Hospital 38 The John Radcliffe 14 North Staffordshire 11 Royal Hallamshire 08 The Walton Centre 07 Newcastle NHS Trust 08 King’s College London 06 UCLH 04 Imperial College 02 Leeds 02 Addenbrooke’s 02 Nottingham 02 Frenchay, North Bristol 01 Royal Preston Website: www.vist.org.uk www.vist.org.uk THANK YOU FOR YOUR CONTINUED SUPPORT 182 www.vist.org.uk STUDY STATUS – next target! The VIST Study is now in Follow-Up Phase, as recruitment was halted on 9th February 2015. A total of 182 patients were recruited to the study, which was a great effort! As planned, 1 year follow-ups will be done by the recruiting site at the scheduled one year visit. Beyond this, annual follow-ups will be done directly by telephone to the patient/contact person by the Coordinating Centre (CC). Where a 1 year follow up visit with your patient is still pending, please review and address all outstanding data queries and requests for missing data wherever possible. Please also review patient contact information and ensure we hold the most current and appropriate contact details to reach our recruited patient population moving forward ! Please provide updates to patient/alternate/GP contact details to me via the VIST email as soon as you become aware of any change. Monthly Site Reports will now focus on Queries addressing missing EVENT data, and the follow up data cleaning effort. Please do not hesitate to contact me if you need any clarification of a query, or support in responding to these requests. Our focus must now be to collect and clean Follow Up Data for all recruited patients to February 2016, to establish a 100% follow up STROKE/TIA Event status for all 182 patients to their 1 year point, adjudicated per the Protocol. I will be working closely with you to identify missing data and capture exhaustive input for all further Events to one year follow up.

3 Does vertebral artery stenting prevent recurrent stroke in symptomatic vertebral artery stenosis? September 2015– Page 2 Final Recruitment Summary # Patients per Centre 77 St. George’s Hospital 38 The John Radcliffe 14 North Staffordshire 11 Royal Hallamshire 08 The Walton Centre 07 Newcastle NHS Trust 08 King’s College London 06 UCLH 04 Imperial College 02 Leeds 02 Addenbrooke’s 02 Nottingham 02 Frenchay, North Bristol 01 Royal Preston Website: www.vist.org.uk www.vist.org.uk THANK YOU FOR YOUR CONTINUED SUPPORT 182 www.vist.org.uk STUDY STATUS – next steps We also wish to collect complete Patient Diaries, (which were distributed to all patients from the 132 nd patient enrolled). Diary data is an important part of the study, to provide information on patient perceptions of their status, and follow up care. Again, where a 1 year follow up visit is still pending, please ensure to collect the dairies and any earlier missing diaries wherever possible. Per patient reminders for outstanding diaries has been highlighted in the Site reports to date, to help you. I will also be reviewing the study SAE reporting, to ensure we have captured and recorded all SAE’s fully, (including follow up forms to event closure) and met SUSAR reporting requirements. THANK YOU! Lindsay VIST EMAIL: vist@medschl.cam.ac.ukvist@medschl.cam.ac.uk VIST FAX: : 01223 217909


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