Pragmatic Ischaemic Stroke Thrombectomy Evaluation: PISTE ?· Pragmatic Ischaemic Stroke Thrombectomy…

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  • Version 1.5

    1st

    September 2014 1

    Pragmatic Ischaemic Stroke Thrombectomy Evaluation: PISTE

    Running title: PISTE

    Protocol Version: 1.5

    Date: 1st

    September 2014

    REC Reference Number: Scotland A REC 12/SS/0059

    NRES Committee North East- Newcastle & North

    Tyneside 2 12-NE-0315 Sponsors Protocol Number: GN11NE257

    Sponsor: NHS Greater Glasgow & Clyde

    Funder: The Stroke Association

    This study will be performed according to the Research Governance Framework for Health and

    Community Care (Second edition, 2006) and The Medicines for Human Use (Clinical Trials)

    Regulations, 2004 SI 2004:1031 (as amended) and WORLD MEDICAL ASSOCIATION DECLARATION OF

    HELSINKI Ethical Principles for Medical Research Involving Human Subjects 1964 (as amended).

  • Version 1.5

    1st

    September 2014 2

    CONTACTS

    Chief Investigator

    Professor Keith Muir

    SINAPSE Professor of Clinical Imaging & Consultant Neurologist

    Institute of Neurosciences & Psychology

    University of Glasgow

    Southern General Hospital

    Glasgow G51 4TF

    Tel: 0141 201 2494

    Fax: 0141 201 2510

    E-mail: keith.muir@glasgow.ac.uk

    Co-investigators

    Professor Philip White

    Professor of Interventional and Diagnostic Neuroradiology

    Newcastle University

    Institute for Ageing & Health

    3-4 Claremont Terrace

    Newcastle upon Tyne

    NE2 4AE

    E-mail: phil.white@ncl.ac.uk

    Project Manager

    Dr Alicia Murray

    Project Manager

    Glasgow Clinical Research Facility

    Tennent Institute

    38 Church Street

    Western Infirmary

    Glasgow G11 6NT

    Email: Alicia.Murray@ggc.scot.nhs.uk

    Trial Statistician

    Professor Ian Ford

    Robertson Centre for Biostatistics

    University of Glasgow

    Data Centre

    Robertson Centre for Biostatistics

    University of Glasgow

    Boyd Orr Building

    University Avenue

    Glasgow G12 8QQ

    Tel: 0141 330 3991

    Chair of Data Safety Monitoring Committee

    Professor Kennedy Lees

    Professor of Cardiovascular Medicine

    College of Medicine, Veterinary & Life Sciences

    Institute of Cardiovascular and Medical Sciences

    Western Infirmary

    Dumbarton Road

    Glasgow G11 6NT

    Tel: 0141 211 2176

    E-mail: kennedy.lees@glasgow.ac.uk

  • Version 1.5

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    September 2014 3

    Chair of the Trial Steering Committee

    Professor Gary Ford

    Level 6 Leazes Wing

    Royal Victoria Infirmary

    Newcastle

    NE1 4LP

    Tel: +44 (0) 191 222 7744

    E-mail: g.a.ford@newcastle.ac.uk

    Pharmacovigilance

    Dr Eleanor Dinnett

    Pharmacovigilance Office

    Glasgow Clinical Trials Unit

    Robertson Centre for Biostatistics

    Boyd Orr Building

    University of Glasgow

    Glasgow G12 8QQ

    Tel: +44(0)141 330 4744

    Fax: +44(0)141 357 5588

    Sponsor

    This clinical trial is sponsored by NHS Greater Glasgow & Clyde.

    Sponsors representative

    Dr Erica Packard

    Research Co-ordinator

    NHS Greater Glasgow & Clyde

    Research and Development Management Office

    Tennent Institute

    38 Church Street

    Western Infirmary

    Glasgow G11 6NT

    Tel: 0141 211 6208

    E-mail: erica.packard@ggc.scot.nhs.uk

    Funding Body

    The Stroke Association

    Stroke House

    240 City Road

    London, EC1V 2PR

  • Version 1.5

    1st

    September 2014 4

    PROTOCOL APPROVAL

    Chief Investigator Professor Keith Muir

    SINAPSE Professor of Clinical Imaging & Consultant Neurologist

    Institute of Neurosciences & Psychology

    University of Glasgow

    Southern General Hospital

    Glasgow G51 4TF

    Signature:

    Date:

    Sponsors representative Dr Erica Packard

    Research Co-ordinator

    NHS Greater Glasgow & Clyde

    Research and Development Management Office

    Tennent Institute

    38 Church Street

    Western Infirmary

    Glasgow G11 6NT

    Signature:

    Date:

  • Version 1.5

    1st

    September 2014 5

    TABLE OF CONTENTS

    CONTACTS ............................................................................................................................... 2 PROTOCOL APPROVAL ................................................................................................................ 4 TABLE OF CONTENTS .................................................................................................................. 5 ABBREVIATIONS ........................................................................................................................ 7 STUDY SYNOPSIS ....................................................................................................................... 8 STUDY FLOW CHART ................................................................................................................ 10 SCHEDULE OF ASSESSMENTS ...................................................................................................... 11

    1. INTRODUCTION ............................................................................................... 12 1.1 Background ..................................................................................................... 12 1.2 Study rationale hypothesis ............................................................................... 15

    2. STUDY OBJECTIVES ........................................................................................... 16 Primary Endpoint ....................................................................................................... 16 Secondary endpoints .................................................................................................. 16 Safety Outcomes ........................................................................................................ 16

    3. STUDY DESIGN ................................................................................................ 16 3.1 Study Population .............................................................................................. 17 3.2 Main inclusion criteria ....................................................................................... 17 3.3 Main exclusion criteria ....................................................................................... 18 3.4 Centre Qualification .......................................................................................... 18 3.5 Identification of participants and consent .............................................................. 19 3.6 Study schedule ................................................................................................. 20 3.7 Modified Rankin Scale ........................................................................................ 22 3.8 Imaging ........................................................................................................... 22

    3.8.1 Image Processing and Analysis..................................................................... 23 3.9 Blood testing / venepuncture .............................................................................. 23

    4. INVESTIGATIONAL DEVICE INFORMATION ............................................................. 24 5. SAFETY REPORTING .......................................................................................... 25

    5.1 Definitions of adverse events .............................................................................. 25 5.2 Definition of Serious Adverse Event ...................................................................... 25 5.3 Recording and reporting of Adverse Events ............................................................ 25 5.4 Expected Adverse Events .................................................................................... 25 5.5 Reporting to sponsor (Pharmacovigilance (PV) Office) .............................................. 26 5.6 Reporting to the Research Ethics Committee (REC) .................................................. 26 5.7 Annual progress report ...................................................................................... 27 5.8 Reporting to local Research and Development (R&D) Departments ............................ 27

    6. STATISTICS AND DATA ANALYSIS ......................................................................... 28 6.1 Statistical analysis plan....................................................................................... 28 6.2 General considerations ...................................................................................... 28 6.3 Primary efficacy variable .................................................................................... 28 6.4 Secondary efficacy analysis ................................................................................. 28 6.5 Safety analysis .................................................................................................. 28 6.6 Software and statistical analysis ........................................................................... 28 6.7 Sample size ...................................................................................................... 28 6.8 Management and delivery .................................................................................. 29

    7. TRIAL CLOSURE / DEFINITION OF END OF TRIAL ...................................................... 30 8. DATA HANDLING ............................................................................................. 31

    8.1 Randomisat

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