Welcome to the BASIL-2 Trial Webpage

Important Trial Update - COVID-19

 

RANDOMISATIONSThe trial is now closed to randomisation. 

Patient follow ups: the follow ups can be done remotely wherever possible, i.e. via telephone and/or hospital notes.  QoL (patient booklets) will still be sent via post to patients.  Sites are asked to maximise follow up data as much as possible. 

Please watch the video where Professor Bradbury talks about importance of data return and re-consenting patients.

Important Message: COVID-19

We are now mostly home-based during the COVID-19 pandemic but available and working. Responses may however take longer than normal as staff may be working altered hours but we are cross covering trials as required and urgent matters will be dealt with promptly. Please do not contact our usual office/landline number and instead email the trial contact and copy in the trial mailbox basil-2@trials.bham.ac.uk. If a query requires a prompt response please mark as ‘urgent’ in the email subject header.

Due to these unprecedented circumstances the trial office proposes the following:

CRFs and consent forms: please DO NOT FAX or POST CRFs and other trial related documents.  Instead please scan and send us the electronic copies;

SAEs:  please DO NOT FAX these.  EMAIL ALL SAEs to trial mailbox basil-2@trials.bham.ac.uk as soon as possible to the trial office mailbox.

 

 

  

We recruited 345 patients and achieved 88.7% of our recruitment target  

**Please read recently updated BASIL-3 website for MHRA statement regarding using drug eluting technologies**

 

Introduction

BASIL-2 is a multi-centre randomised controlled trial to find out if a ‘vein bypass first’ or a ‘best endovascular first’ revascularisation strategy is best, in terms of either clinical or cost-effectiveness, for severe limb ischaemia due to infra-popliteal disease.

Severe limb ischemia is the most severe form of lower limb peripheral artery disease and is a seriously disabling, life and limb threatening, condition. The aim of BASIL-2 is to evaluate the effectiveness and cost-effectiveness of these interventions  for people with severe limb ischaemia.

 

The BASIL-2 Trial is funded by a NIHR Health Technology Assessment grant (project number 12/35/45)

Trial Progress

BASIL-2 officially began its recruitment phase in July 2014 with its first randomisation from the lead centre (Heart of England NHS Foundation Trust).

A total of 41 clinical centres were open to the end of Basil-2 trial; 31 in England, 3 in Scotland, 2 in Wales, 3 in Denmark, and 2 in Sweden.  39 of the 41 clinical centres have cumulatively recruited 345 participants out of a revised sample size of 389 patients.  

 

BASIL-2 Trial Centres

BASIL-2 Trial Centres
Trial Centre Date Green Light Issued
 Heartlands 11/06/2014 
 Newcastle General 11/07/2014 
 Southampton 02/09/2014 
 Russell's Hall 29/09/2014 
 Hull & York Hospitals 30/09/2014 
 North Durham 17/10/2014 
 Sheffield 17/10/2014 
 South Manchester 21/10/2014 
 Aberdeen 07/11/2014 
 Leeds Teaching Hospital 10/11/2014 
 Worcester 02/12/2014 
 Imperial 10/12/2014 
 Royal Free, London 12/12/2014 
 Guy's and St. Thomas' 13/01/2015 
 Royal Cornwall 03/02/2015 
 UHB 06/02/2015 
 Sandwell & West Birmingham Hospital 09/02/2015 
 St George's 16/02/2015 
 North Cumbria 16/02/2015 
 Leicester 04/03/2015 
 Western Infirmary, Glasgow 04/03/2015 
 Frimley Park 09/03/2015 
 Royal Infirmary, Edinburgh 20/03/2015 
 UHCW 27/03/2015 
 Oxford 24/04/2015 
 Northwest London (Northwick Park) 28/05/2015 
 Manchester Royal 28/05/2015 
Royal Gwent 03/06/2015
 Ninewells, Dundee (NHS Tayside) 17/06/2015 
 Addenbrookes 23/06/2015 
 Royal Bournemouth 24/07/2015 
 James Cook 27/07/2015
 Kent & Canterbury 27/07/2015 
 Norfolk & Norwich 10/08/2015 
 Cardiff (UHW) 13/08/2015 
 Royal Sussex 19/08/2015 
 Royal Oldham 14/09/2015 
 Colchester General 22/09/2015 
 Doncaster Royal Infirmary 28/09/2015 
 Barts and the London 02/10/2015
 York 14/10/2015
 Torbay 25/11/2015
 Royal Blackburn 03/12/2015 
 United Lincolnshire Hospitals 06/01/2016 
 Gloucester Hospitals 29/01/2016 
 Portsmouth (Queen Alexandra) 01/03/2016 
 Taunton 16/03/2016
 Kolding (Denmark) 18/04/2016 
 Royal Preston 11/05/2016 
 Southmead (Bristol) 16/05/2016
Bradford Royal Infirmary 14/09/2016
Sodersjukhuset (sweden) 01/12/2016
Aarlborg (Denmark) 03/04/2017
Stirling (NHS Forth Valley) 04/04/2017
Odense (Denmark) 12/06/2017
Karolinska 28/05/2019

You can also see our clinical centres on the map.

For a more in depth overview of recruitment to BASIL-2, visit our recruitment page.