Bypass Vs. Angioplasty in Severe Ischaemia of the Leg-2
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Multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of a ‘vein bypass first’ with a ‘best endovascular treatment first’ revascularisation strategy for severe limb ischaemia due to infra-popliteal arterial disease Bypass vs. Angioplasty in Severe Ischaemia of the Leg-2 TRIAL PROTOCOL: Version 4.0 26 July 2016 Sponsor: University of Birmingham Chief Investigator: Professor Andrew Bradbury Coordinating Centre: Birmingham Clinical Trials Unit Funder: NIHR Health Technology Assessment programme ISRCTN: 27728689 Main REC Ref. No.: 14/WM/0057 Version 4.0, 26 July 2016 TRIAL COMMITTEES AND CONTACT Trial Management Group Chief Investigator Sampson Gamgee Professor of Vascular Surgery Professor Andrew Bradbury University of Birmingham Email: [email protected] Co-Applicants Southampton: Professor Shearman; Dr Odurny St George’s, London: Mr Hinchliffe; Professor Belli Imperial College, London: Professor Davies; Dr Burfitt Oxford: Mr Perkin; Dr Uberoi Birmingham: Mr Claridge; Dr Ganeshan; Leicester : Professor Naylor; Dr Adair Hull: Professor Chetter; Professor Ettles Leeds: Professor Scott; Dr Patel Sheffield: Professor Beard; Dr Cleveland Newcastle: Professor Stansby; Dr Jackson Scotland: Professor Brittenden; Dr Robertson Birmingham Clinical Trials Unit Director: Jon Deeks Birmingham Clinical Trials Unit, University of Birmingham Email: [email protected] Statistician: Smitaa Patel Birmingham Clinical Trials Unit, University of Birmingham Email: [email protected] Trial Management: Margaret Grant Birmingham Clinical Trials Unit, University of Birmingham Email: [email protected] Trial Coordinator: Hugh Jarrett Birmingham Clinical Trials Unit, University of Birmingham Email: [email protected] Health Economist: Lazaros Health Economics Unit, School of Health and Population Sciences, University of Birmingham Andronis Email: [email protected] Lead Research Nurse: Gareth Solihull Hospital, Heart of England NHS Foundation Trust Bate Email: [email protected] ISRCTN: 27728689 Page 1 Version 4.0, 26 July 2016 Trial Steering Committee Chair: Professor Jonathan Honorary Professor of Clinical Decision Science, Health Michaels Economics and Decision Science, ScHARR, University of Sheffield Email: [email protected] Mr James Griffin Research Associate, University of Warwick Email: [email protected] Prof Jon Moss Consultant Vascular Interventional Radiologist, Southern General Hospital Email: [email protected] Professor Michael Gough Professor of Vascular Surgery and Head of School of Surgery, University of Leeds Email: [email protected] Mr Andrew Beech Chief Vascular Scientist, Nottingham University Hospitals Email: [email protected] Prof Frances Game Consultant Diabetologist Email: [email protected] Martin Fox Vascular Specialist Podiatrist, Huddersfield Email: [email protected] Mr Peter Maufe PAD patient, Patient Representative Email: [email protected] Mr Barry Attwood PAD patient, Patient Representative Email: [email protected] Dr Nick Latimer Senior Research Fellow in Decision Science, ScHARR, University of Sheffield Email: [email protected] Lisa Smith Clinical Nurse Specialist, Pennine Acute Hospitals Trust Email: [email protected] ISRCTN: 27728689 Page 2 Version 4.0, 26 July 2016 Data Monitoring Committee Chair: Professor Doug Altman Director of Centre for Statistics in Medicine and Cancer Research UK Medical Statistics Group, University of Oxford Email: [email protected] Professor Charles McCollum Professor of Surgery, University of Manchester Email: [email protected] Dr Michael Flynn Consultant Diabetologist, Kent and Canterbury Hospital, Canterbury Email: [email protected] Professor Peter Gaines Professor of Vascular Interventional Radiology, Northern General Hospital, Sheffield Email: [email protected] BASIL-2 Trial Office For general protocol related queries and supply of trial materials: Birmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, College of Medical & Dental Sciences, Public Health Building, University of Birmingham, Edgbaston, Birmingham B15 2TT Telephone: 0121 415 9108 (answering machine outside office hours) Fax: 0121 415 9136 Email: [email protected] Website: www.birmingham.ac.uk/basil2 Randomisation The randomisation procedure is described in section 5.3 Telephone: 0800 953 0274 Website: www.birmingham.ac.uk/basil2 Safety Reporting Safety reporting is described in Section 6 Fax SAE Forms to: 0121 415 9135 ISRCTN: 27728689 Page 3 Version 4.0, 26 July 2016 Chief Investigator and Sponsor Signatures The Chief Investigator and Sponsor have discussed and agree to abide by this this protocol and to conduct the trial in compliance with EU Good Clinical Practice (GCP), the UK Data Protection Act (1998), the Trust Information Governance Policy (or other local equivalent) and the Research Governance Framework (2005 2nd Edition; as amended). Chief investigator Professor Andrew Bradbury Signature Date Sponsor Representative Dr Sean Jennings University of Birmingham Signature Date This protocol describes the BASIL-2 trial only. The trial will be conducted in accordance with the protocol and GCP. Every care has been taken in the drafting of this protocol, but future amendments may be necessary, which will receive the required approvals prior to implementation. ISRCTN: 27728689 Page 4 Version 4.0, 26 July 2016 Principal Investigator Signature Page Principal Investigator: I have read and agree to the protocol, as detailed in this document. I agree to adhere to the protocol as outlined and agree that any suggested changes to the protocol must be approved by the Trial Steering Committee prior to seeking approval from the Health Research Authority (HRA). I am aware of my responsibilities as an Investigator under the guidelines of Good Clinical Practice (GCP), the Declaration of Helsinki and the trial protocol and I agree to conduct the trial according to these guidelines and to appropriately direct and assist the staff under my control, who will be involved in the trial. Principal investigator <insert name> Signature Date Name of Institution <insert name> The Principal Investigator should sign this page and return a copy to the BASIL-2 Trial Office ISRCTN: 27728689 Page 5 Version 4.0, 26 July 2016 Table of Contents 1 Trial Summary ..................................................................................................... 12 1.1 Trial Schema (Figure 1) .................................................................................. 15 2 Introduction......................................................................................................... 15 2.1 BASIL-2 and NICE ........................................................................................ 17 2.2 BASIL-2 and the HTA ................................................................................... 18 2.3 Assessment and Management of Risk ............................................................ 18 3 Trial Design ......................................................................................................... 18 3.1 Trial Objective ................................................................................................ 19 3.2 Primary Outcome Measure ............................................................................. 19 3.3 Secondary Outcome Measures: ...................................................................... 19 3.4 Selection of Participants ................................................................................. 19 3.5 Inclusion Criteria ............................................................................................ 20 3.6 Exclusion Criteria ........................................................................................... 21 4 Trial Procedures and Schedule of Assessments ................................................ 21 4.1 Informed Consent Procedure .......................................................................... 22 4.2 Baseline Assessments ..................................................................................... 23 4.3 Randomisation Procedures and Minimisation ................................................ 24 4.4 Baseline Assessment....................................................................................... 25 4.5 Best Endovascular Treatment ......................................................................... 26 4.6 Vein Bypass .................................................................................................... 27 4.7 Amputation ..................................................................................................... 27 4.8 In-patient Follow-up ....................................................................................... 27 4.9 Follow-up Visit ............................................................................................... 28 4.10 Assessment Schedule (Table 1) ...................................................................... 29 5 Recording and Reporting of Adverse Events ...................................................... 29 5.1 Safety Reporting Procedures .......................................................................... 30 5.2 AE Definition and Reporting .......................................................................... 30 5.3 SAE Definition and Reporting ....................................................................... 30 5.4 Summary