Welcome to the BASIL-2 Trial Webpage
Important Trial Update - COVID-19
RANDOMISATIONS: The 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.
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
| 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.