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