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Welcome to the BASIL-3 Trial Webpage

*** The BASIL-3 protocol paper has now been published in "Trials" and can be accessed from their website ***

Introduction 

Basil-3 is a multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents, and plain balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia secondary to femoro-popliteal disease.

Severe limb ischemia is the most serious and debilitating form of lower limb peripheral artery disease and is a seriously disabling, life and limb threatening, condition. The aim of BASIL-3 is to evaluate the clinical efficacy and cost-effectiveness of the interventions for people with severe limb ischaemia.

 

nihr_colourThe BASIL-3 Trial is funded by a NIHR Health Technology Assessment grant (project number 13/81/02).

Trial Progress

Basil-3 officialy began its 3-year recruitment phase in February 2016, however due to receiving regulatory approval ahead of schedule, the lead centre (Heart of England NHS Foundation Trust) successfully entered the trial's first two participants during January of 2016. Since then, the trial has managed to meet or exceed each of its monthly targets, which are set by the National Institute for Health Research's HTA programme. This early success has firmly placed the cumulative recruitment total ahead of schedule.

As of 25 MAY 2017, a total of 31 clinical centres are open to recruit to the Basil-3 trial; 27 in England, 2 in Scotland, and 2 in Wales.  Twenty-six of the 31 clinical centres have cumulatively recruited 166 participants. We have 2 clinical centres which we anticipate will open to recruitment in the next 30 days. Tens of centres have formally expressed interest in opening Basil-3 and are at varying stages of start-up; we anticipate the majority of these opening within the next six months.

 

Basil-3 Trial Centres

 

Clinical centres currently open to recruit to Basil-3
 Centre name Local PI Opened
North Cumbria University Hospitals  Mr Ron Eifell 12-Jan-16 
Royal Cornwall Hospitals Mr Harvey Chant  19-Jan-16
Heart of England NHS FT Prof. Andrew Bradbury  19-Jan-16
Sheffield Teaching Hospitals Dr Stephen Goode 24-Feb-16 
Pennine Acute Hospitals Dr Khalid Bashaeb 14-Mar-16
County Durham and Darlington Mr Philip Davey 18-Mar-16
East Kent Hospitals Dr Neelan Das 07-Apr-16
Colchester Hospital University Dr Nagendra Thayur  24-May-16 
Dorset County Hospital Mr James Metcalfe  28-May-16 
Imperial College Healthcare Prof. Alun Davies  21-Jun-16 
Aneurin Bevan Health Board Mr Christopher Twine  21-Jun-16 
United Lincolnshire Hospitals Dr Geurino Centini  11-Aug-16
Russell's Hall Hospital (Dudley) Mr Simon Hobbs 23-Aug-16
Nottingham University Hospitals Dr Said Habib 09-Sep-16
Basildon Hospital Dr Jeremy Rabouhans 12-Sep-16
University Hospitals of North Midlands Dr John Asquith 07-Oct-16
Freeman Hospital (Newcastle) Prof. Gerard Stansby 19-Oct-16
Frimley Park Hospital Mr Patrick Chong 08-Nov-16
Royal Infirmary of Edinburgh Dr Graeme Weir 18-Nov-16
Leeds General Infirmary Dr Jai Patel 18-Nov-16
Royal Wolverhampton Hospitals Mr Simon Hobbs 13-Dec-16
Leicester Royal Infirmary Mr Robert Davies 30-Jan17
University Hospital of Wales Dr Richard White 31-Jan-17
Dumfries and Galloway Royal Infirmary Mr Joseph Sathianathan 31-Jan-17
Royal Sussex County Hospital Mr Mario Caruana 07-Feb-17
Hull Royal Infirmary Prof. Ian Chetter 09-Feb-17
St. Thomas' Hospital Mr Hany Zayed 28-Feb-17
Southmead Hospital (Bristol) Dr Alexander Horsch 13-Apr-17
Royal Bournemouth Mr Lasantha Wijesinghe 17-May-17
University Hospital of South Manchester Mr Ray Ashleigh 19-May-17
Manchester Royal Infirmary Mr Tawqeer Rashid 25-May-17

 

You can also see our clinical centres on the map.

The Basil-3 trial team are still accepting expressions of interest from UK-based vascular centres. NHS Trusts in England and Health Boards in the devolved nations should contact the Basil-3 trial office with the name of their proposed Principal Investigator to begin the start-up process for their site. We would typically expect a site Principal Investigator to be a Consultant Interventional Radiologist or a Consultant Vascular Surgeon with prior clinical research experience. Please see the contact us page for details of how to get in touch.

Current Basil-3 Recruitment (as of end of APR 2017)

 Cumulative_APRIL17

For a more in depth overview of recruitment to Basil-3, visit our recruitment page.